Colorectal PolypsCADxGIGNCT07738484
AI-Assisted Optical Diagnosis (CADx) for Diminutive Colorectal Polyps
An observational study of Colorectal Polyps and Colorectal Adenoma, run by Centre hospitalier de l'Université de Montréal (CHUM).
Trial summary
This study evaluates whether an artificial intelligence system (GI Genius, Medtronic), already approved by Health Canada, can help doctors accurately identify, in real time during colonoscopy, which small colorectal polyps (5 mm or less) need to be monitored (adenomas) versus those that do not (for example… Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Colorectal Polyps, Colorectal Adenoma, Diminutive Colorectal Polyp
- What is being tested?
- GI Genius CADx module (Medtronic)
- Type of treatment
- Medical device
- How many people
- 840 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Aug 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients aged 45-80 years undergoing elective colonoscopy (screening, surveillance, or diagnostic) at three Canadian academic centres (CHUM, CUSM, St. Paul's Hospital), providing written informed consent before the procedure and before sedation. Patients become eligible for the analytic cohort if at least one diminutive polyp (≤5 mm) is detected during colonoscopy; those without an eligible polyp are recorded as screen failures. Key exclusions: inflammatory bowel disease, active colitis, coagulopathy/thrombocytopenia, familial polyposis syndrome, ASA >III, emergency colonoscopy, or inadequate bowel preparation. Target: 840 patients (~1,605 diminutive polyps) across the three centres over 24 months.
Who may be able to join
- Signed informed consent, obtained before the colonoscopy and before sedation
- Age 45-80 years
- Indication for elective colonoscopy (screening, surveillance, or diagnostic)
- At least one diminutive polyp (≤5 mm) detected during the procedure (required for inclusion in the analytic cohort; consented patients without an eligible polyp are documented as screen failures)
Who cannot join
- Known inflammatory bowel disease
- Active colitis
- Coagulopathy or thrombocytopenia (INR ≥1.5 or platelets <50×10⁹/L)
- Familial polyposis syndrome
- American Society of Anesthesiologists classification >III
- Emergency colonoscopy
- Inadequate bowel preparation (Boston Bowel Preparation Scale <6)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Daniel von Renteln, Doctor of Medicine (MD), Gastr contact
About this study
Official title: Prospective Multicenter Validation of an Artificial Intelligence-Assisted Optical Diagnosis Strategy (CADx) for the Real-Time Characterization of Diminutive Colorectal Polyps: A STARD-Compliant Diagnostic Accuracy Study
This study evaluates whether an artificial intelligence system (GI Genius, Medtronic), already approved by Health Canada, can help doctors accurately identify, in real time during colonoscopy, which small colorectal polyps (5 mm or less) need to be monitored (adenomas) versus those that do not (for example, hyperplastic polyps). For each small polyp found, the endoscopist will first record a diagnosis without the help of the artificial intelligence system, then activate the system and record a second diagnosis after seeing its assessment. Both diagnoses will be compared to the final result from standard pathology testing, which remains the reference standard. This is an observational diagnostic accuracy study: it does not change any clinical care. All polyps continue to be removed and sent for pathology analysis as usual, whether or not the artificial intelligence system agrees with the doctor. The study will take place during colonoscopies already scheduled for standard clinical reasons (screening, surveillance, or diagnostic work-up), with no additional visits, blood draws, imaging, or sedation. Approximately 840 participants will be enrolled across three Canadian centres (Santé Québec - CHUM, McGill University Health Centre, and St. Paul's Hospital, Vancouver). The goal is to determine whether this AI-assisted approach helps doctors reach the internationally recognized performance thresholds (at least 80% sensitivity and 80% specificity) needed to support clinical adoption of real-time optical diagnosis, which could eventually reduce unnecessary pathology testing.
Read the detailed description
Colonoscopy with polypectomy is the cornerstone of colorectal cancer (CRC) screening and prevention. The majority of polyps detected during colonoscopy are diminutive (≤5 mm) and carry a very low risk of harbouring advanced pathology. In Canada, over 1.9 million colonoscopies are performed annually, and sending all diminutive polyps for histopathological examination (at a cost of approximately $150-$300 CAD per specimen) generates a substantial economic burden with limited benefit for cancer prevention.
Two international guideline frameworks define the performance thresholds required for clinical adoption of optical diagnosis strategies for diminutive colorectal polyps. The ASGE PIVI initiative (2011) established (1) ≥90% negative predictive value (NPV) for adenomatous histology among diminutive rectosigmoid polyps diagnosed with high confidence ("diagnose-and-leave" threshold), and (2) ≥90% agreement between optical-diagnosis-based and pathology-based post-polypectomy surveillance intervals ("resect-and-discard" threshold). The more recent ESGE SODA position statement (2022) adopted sensitivity and specificity as the foundational, prevalence-independent performance measures for high-confidence real-time characterization of colorectal neoplasia, applicable across all colonic locations: sensitivity ≥90% and specificity ≥80% for the rectosigmoid subset, and sensitivity ≥80% and specificity ≥80% across all diminutive colorectal polyps regardless of location.
The investigators' research group has previously conducted several single-centre studies evaluating early-generation, Health Canada-approved computer-aided diagnosis (CADx) systems in routine clinical practice, generating one of the largest real-world CADx implementation datasets in the literature (868 patients, 1,660 diminutive polyps). These studies consistently demonstrated suboptimal overall diagnostic accuracy (62.7%-66.4%), attributable to restricted training datasets and limited polyp-classification capabilities in early-generation devices. GI Genius (Medtronic), the newer-generation, Health Canada-approved CADx module evaluated in this study, was trained on a larger and more diverse dataset of annotated endoscopic images and videos. Whether this translates into measurable gains in diagnostic performance sufficient to meet international competence thresholds has not been established in an independent, prospective, multicentre study, and is the question this study addresses.
This is a prospective, three-centre diagnostic accuracy study conducted in accordance with the Standards for Reporting Diagnostic Accuracy Studies (STARD 2015). It is a single-arm study validating a CADx-assisted optical-diagnosis strategy - rather than autonomous or standalone CADx performance - in which the endoscopist's final CADx-assisted optical diagnosis constitutes the primary index test. For each diminutive polyp (≤5 mm) identified during an already-scheduled elective colonoscopy, the following sequential steps are performed: (1) the endoscopist records a CADx-unassisted optical diagnosis (adenoma, hyperplastic polyp, or other) and confidence level (high or low), which is electronically locked before any device output is viewed; (2) the CADx module is activated and displays its own characterization of the polyp; (3) the endoscopist records a final CADx-assisted optical diagnosis and confidence level, remaining free to agree or disagree with the device; (4) a research assistant documents polyp size, morphology (Paris classification), and colonic location; and (5) the polyp is resected per standard technique and sent for histopathological examination, which serves as the reference standard. This sequential-locking design - recording and locking the unassisted diagnosis before CADx activation - is the study's key strategy for minimizing contamination bias between the two diagnostic strategies, and allows each polyp to generate two paired diagnostic data points (CADx-unassisted and CADx-assisted) compared against a single histopathological reference standard.
The study will enroll consecutive patients aged 45-80 years undergoing elective colonoscopy (screening, surveillance, or diagnostic indication) at three Canadian academic centres: Santé Québec - CHUM (Montreal), the McGill University Health Centre (MUHC/CUSM, Montreal), and St. Paul's Hospital (Vancouver), who provide written informed consent before the colonoscopy and before sedation.
Inclusion criteria: signed informed consent obtained before the colonoscopy and before sedation; age 45-80 years; indication for elective colonoscopy (screening, surveillance, or diagnostic); and at least one diminutive polyp (≤5 mm) detected during the procedure, which is required for inclusion in the analytic cohort (consented patients in whom no eligible polyp is detected are documented as screen failures and do not contribute to the primary analysis).
Exclusion criteria: known inflammatory bowel disease; active colitis; coagulopathy or thrombocytopenia (INR ≥1.5 or platelets <50×10⁹/L); familial polyposis syndrome; American Society of Anesthesiologists (ASA) classification >III; emergency colonoscopy; and inadequate bowel preparation (Boston Bowel Preparation Scale <6).
All staff gastroenterologists and gastroenterology trainees performing elective colonoscopies at participating centres are eligible to participate as endoscopists, with no additional optical-diagnosis training provided, reflecting real-world implementation conditions.
The primary objective is to determine the sensitivity and specificity of CADx-assisted optical diagnosis for adenomatous histology among all diminutive colorectal polyps, benchmarked against the ESGE SODA competence thresholds (sensitivity ≥80%, specificity ≥80%), using histopathology as the reference standard. Secondary objectives include: the NPV of CADx-assisted diagnosis among high-confidence diminutive rectosigmoid polyps (ASGE PIVI threshold ≥90%); agreement between CADx-assisted and pathology-based surveillance interval recommendations (ASGE PIVI threshold ≥90%); sensitivity and specificity for the rectosigmoid subset (ESGE SODA threshold: sensitivity ≥90%, specificity ≥80%); a paired comparison of CADx-assisted versus CADx-unassisted diagnostic performance; diagnostic confidence calibration; and the proportion of CADx-assisted diagnoses made with high confidence. Prespecified exploratory subgroup analyses will evaluate diagnostic performance by polyp size (≤3 mm vs. 4-5 mm), morphology, colonic location, endoscopist experience level, patient biological sex, and study centre. A tertiary/exploratory objective is an integrated health economic evaluation - combining a decision tree and a state-transition Markov model, from both health-system and societal perspectives - assessing the cost-effectiveness of a possible future CADx-assisted "resect-and-discard"/"diagnose-and-leave" strategy compared with universal histopathological examination, with results reported per the CHEERS 2022 checklist.
A minimum of 826 patients is required to evaluate both co-primary outcomes (sensitivity and specificity) with an overall power of 80%, accounting for intra-patient clustering of polyps (design effect 1.3, based on an average of 1.91 diminutive polyps per patient and an intraclass correlation of 0.3). A recruitment target of 840 patients (approximately 1,605 diminutive polyps), enrolled evenly across the three centres (280 per centre) over an expected 24-month recruitment period, has been set to exceed this minimum. Sensitivity and specificity will be estimated using generalized linear mixed models with a logit link and a random effect for patient, to account for clustering of polyps within patients; each one-sided hypothesis test (H₀: sensitivity or specificity ≤80%) will be conducted at α=0.025, with study success requiring rejection of both null hypotheses. Prespecified sensitivity analyses include a per-protocol analysis, a high-confidence-only analysis aligned with formal ESGE SODA competence assessment, a reclassification of serrated lesions as neoplastic, models incorporating a random effect for endoscopist, and a temporal analysis for learning-curve or fatigue effects. No interim analyses are planned; all analyses will be conducted after complete enrolment.
There is no increased risk to participants beyond the standard risks of colonoscopy, since all polyps are resected according to usual clinical practice regardless of study participation, and no additional procedures (blood sampling, imaging, additional sedation, or follow-up visits) are performed for research purposes. This is an investigator-initiated study (Sponsor-Investigator: Dr. Daniel von Renteln, CHUM/CRCHUM); Medtronic Canada provides the GI Genius CADx equipment on loan for the study period, together with related installation and technical support only, and has no role in study design, recruitment, data collection, endpoint adjudication, statistical analysis, interpretation, or publication decisions.
- Being tested
- GI Genius CADx module (Medtronic)
- Keywords
- CADx, Computer-Aided Diagnosis, Optical Diagnosis, Colonoscopy, Diminutive Colorectal Polyps, Colorectal Adenoma, GI Genius, Artificial Intelligence, Diagnostic Accuracy, Real-time Characterization, STARD, Histopathology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GI Genius CADx module (Medtronic)Device
Computer-aided diagnosis (CADx) device recently approved by Health Canada, used to provide real-time optical characterization of diminutive colorectal polyps (≤5 mm) during colonoscopy. For each diminutive polyp detected, the endoscopist first records a CADx-unassisted optical diagnosis (electronically locked before device activation), then activates the GI Genius CADx module, which displays a device-provided characterization. The endoscopist then records a final CADx-assisted optical diagnosis, which may agree or disagree with the device output. The study evaluates the CADx-assisted optical-diagnosis strategy (endoscopist + device combined) rather than autonomous or standalone CADx performance.
| Study group | Role | What they receive |
|---|---|---|
| Diminutive Colorectal Polyps - CADx-Assisted Optical Diagnosis | Consecutive patients aged 45-80 undergoing elective colonoscopy (screening, surveillance, or diagnostic) at CHUM, CUSM, and St. Paul's Hospital who provide written informed consent before the colonoscopy and before sedation, and in whom at least one diminutive polyp (≤5 mm) is detected during the procedure. For each diminutive polyp, the endoscopist first records a CADx-unassisted optical diagnosis and confidence level (electronically locked before device activation), then activates the GI Genius CADx module, and records a final CADx-assisted optical diagnosis and confidence level after viewing the device-provided characterization. All polyps are resected and sent for histopathological examination, which serves as the reference standard. Receives: Device: GI Genius CADx module (Medtronic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of CADx-assisted optical diagnosis for adenomatous histology
Number of correct adenomatous optical diagnoses divided by the number of histologically confirmed adenomas, among all diminutive (≤5 mm) colorectal polyps, benchmarked against the ESGE SODA threshold (≥80%)
Measured: Within 14 to 45 days after polypectomy (colorectal polyp resection during the index colonoscopy), once histopathology results are available
Specificity of CADx-assisted optical diagnosis for adenomatous histology
Number of correct non-adenomatous optical diagnoses divided by the number of histologically confirmed non-adenomas, among all diminutive (≤5 mm) colorectal polyps, benchmarked against the ESGE SODA threshold (≥80%)
Measured: Within 14 to 45 days after polypectomy (colorectal polyp resection during the index colonoscopy), once histopathology results are available
Secondary outcomes (6)
NPV of CADx-assisted optical diagnosis for adenomatous histology (rectosigmoid, high confidence)
Benchmark : ASGE PIVI ≥90%.
Measured: Within 14 to 45 days after polypectomy (colorectal polyp resection during the index colonoscopy), once histopathology results are available
Surveillance interval agreement
Proportion of patients with agreement between CADx-assisted and pathology-based surveillance interval recommendations (ASGE PIVI ≥90%).
Measured: Outcome assessed throughout the 24-month recruitment period, with total study duration of 36 months
Sensitivity and specificity, rectosigmoid subset
ESGE SODA Recommendation 1 (sensitivity ≥90%, specificity ≥80%)
Measured: Outcome assessed throughout the 24-month recruitment period, with total study duration of 36 months
CADx-assisted vs. CADx-unassisted diagnostic performance
Paired within-polyp comparison of adenoma sensitivity/specificity
Measured: Outcome assessed throughout the 24-month recruitment period, with total study duration of 36 months
High-confidence prediction rate
Proportion of CADx-assisted diagnoses made with high confidence
Measured: Outcome assessed throughout the 24-month recruitment period, with total study duration of 36 months
Confidence calibration
Adenoma sensitivity/specificity among high- vs. low-confidence diagnoses, for both CADx-assisted and unassisted strategies
Measured: Outcome assessed throughout the 24-month recruitment period, with total study duration of 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Colorectal PolypsStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 840 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07738484
- Sponsor's protocol ID
- MP-02-2027-13785
- Acronym
- CADxGIG
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data collected in this study will not be made publicly available. Patient data are coded and stored securely in compliance with institutional privacy policies at all three participating sites (CHUM, CUSM, St. Paul's Hospital). While the protocol allows for retention of study data for future research purposes (e.g., further characterization of polyp features or continued AI model development), this secondary use is limited to the study's own research team and governed by the original research ethics board approval, rather than through open public sharing of individual-level data. No data-sharing repository, external access mechanism, or de-identification/sharing procedure for external investigators is specified in the protocol.
Publications
Hassan C, Spadaccini M, Iannone A, Maselli R, Jovani M, Chandrasekar VT, Antonelli G, Yu H, Areia M, Dinis-Ribeiro M, Bhandari P, Sharma P, Rex DK, Rosch T, Wallace M, Repici A. Performance of artificial intelligence in colonoscopy for adenoma and polyp detection: a systematic review and meta-analysis. Gastrointest Endosc. 2021 Jan;93(1):77-85.e6. doi: 10.1016/j.gie.2020.06.059. Epub 2020 Jun 26.
PubMed 32598963Biffi C, Salvagnini P, Dinh NN, Hassan C, Sharma P; GI Genius CADx Study Group; Cherubini A. A novel AI device for real-time optical characterization of colorectal polyps. NPJ Digit Med. 2022 Jun 30;5(1):84. doi: 10.1038/s41746-022-00633-6.
PubMed 35773468Byrne MF, Chapados N, Soudan F, Oertel C, Linares Perez M, Kelly R, Iqbal N, Chandelier F, Rex DK. Real-time differentiation of adenomatous and hyperplastic diminutive colorectal polyps during analysis of unaltered videos of standard colonoscopy using a deep learning model. Gut. 2019 Jan;68(1):94-100. doi: 10.1136/gutjnl-2017-314547. Epub 2017 Oct 24.
PubMed 29066576Mori Y, Kudo SE, Misawa M, Saito Y, Ikematsu H, Hotta K, Ohtsuka K, Urushibara F, Kataoka S, Ogawa Y, Maeda Y, Takeda K, Nakamura H, Ichimasa K, Kudo T, Hayashi T, Wakamura K, Ishida F, Inoue H, Itoh H, Oda M, Mori K. Real-Time Use of Artificial Intelligence in Identification of Diminutive Polyps During Colonoscopy: A Prospective Study. Ann Intern Med. 2018 Sep 18;169(6):357-366. doi: 10.7326/M18-0249. Epub 2018 Aug 14.
PubMed 30105375Husereau D, Drummond M, Augustovski F, de Bekker-Grob E, Briggs AH, Carswell C, Caulley L, Chaiyakunapruk N, Greenberg D, Loder E, Mauskopf J, Mullins CD, Petrou S, Pwu RF, Staniszewska S; CHEERS 2022 ISPOR Good Research Practices Task Force. Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) statement: updated reporting guidance for health economic evaluations. BMJ. 2022 Jan 11;376:e067975. doi: 10.1136/bmj-2021-067975.
PubMed 35017145Hassan C, Pickhardt PJ, Rex DK. A resect and discard strategy would improve cost-effectiveness of colorectal cancer screening. Clin Gastroenterol Hepatol. 2010 Oct;8(10):865-9, 869.e1-3. doi: 10.1016/j.cgh.2010.05.018. Epub 2010 Jun 1.
PubMed 20621680Djinbachian R, Haumesser C, Taghiakbari M, Pohl H, Barkun A, Sidani S, Liu Chen Kiow J, Panzini B, Bouchard S, Deslandres E, Alj A, von Renteln D. Autonomous Artificial Intelligence vs Artificial Intelligence-Assisted Human Optical Diagnosis of Colorectal Polyps: A Randomized Controlled Trial. Gastroenterology. 2024 Jul;167(2):392-399.e2. doi: 10.1053/j.gastro.2024.01.044. Epub 2024 Feb 7.
PubMed 38331204Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig L, Lijmer JG, Moher D, Rennie D, de Vet HC, Kressel HY, Rifai N, Golub RM, Altman DG, Hooft L, Korevaar DA, Cohen JF; STARD Group. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ. 2015 Oct 28;351:h5527. doi: 10.1136/bmj.h5527.
PubMed 26511519Dekker E, Houwen BBSL, Puig I, Bustamante-Balen M, Coron E, Dobru DE, Kuvaev R, Neumann H, Johnson G, Pimentel-Nunes P, Sanders DS, Dinis-Ribeiro M, Arvanitakis M, Ponchon T, East JE, Bisschops R. Curriculum for optical diagnosis training in Europe: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement. Endoscopy. 2020 Oct;52(10):899-923. doi: 10.1055/a-1231-5123. Epub 2020 Sep 3.
PubMed 32882737Houwen BBSL, Hassan C, Coupe VMH, Greuter MJE, Hazewinkel Y, Vleugels JLA, Antonelli G, Bustamante-Balen M, Coron E, Cortas GA, Dinis-Ribeiro M, Dobru DE, East JE, Iacucci M, Jover R, Kuvaev R, Neumann H, Pellise M, Puig I, Rutter MD, Saunders B, Tate DJ, Mori Y, Longcroft-Wheaton G, Bisschops R, Dekker E. Definition of competence standards for optical diagnosis of diminutive colorectal polyps: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement. Endoscopy. 2022 Jan;54(1):88-99. doi: 10.1055/a-1689-5130. Epub 2021 Dec 6.
PubMed 34872120ASGE Technology Committee; Abu Dayyeh BK, Thosani N, Konda V, Wallace MB, Rex DK, Chauhan SS, Hwang JH, Komanduri S, Manfredi M, Maple JT, Murad FM, Siddiqui UD, Banerjee S. ASGE Technology Committee systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting real-time endoscopic assessment of the histology of diminutive colorectal polyps. Gastrointest Endosc. 2015 Mar;81(3):502.e1-502.e16. doi: 10.1016/j.gie.2014.12.022. Epub 2015 Jan 16.
PubMed 25597420Rex DK, Kahi C, O'Brien M, Levin TR, Pohl H, Rastogi A, Burgart L, Imperiale T, Ladabaum U, Cohen J, Lieberman DA. The American Society for Gastrointestinal Endoscopy PIVI (Preservation and Incorporation of Valuable Endoscopic Innovations) on real-time endoscopic assessment of the histology of diminutive colorectal polyps. Gastrointest Endosc. 2011 Mar;73(3):419-22. doi: 10.1016/j.gie.2011.01.023.
PubMed 21353837
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Validation of an Artificial Intelligence-Assisted Optical Diagnosis Strategy (CADx) for the Real-Time Characterization of Diminutive Colorectal Polyps: A STARD-Compliant Diagnostic Accuracy Study
- ClinicalTrials.gov ID
- NCT07738484
- Acronym / sponsor ID
- CADxGIG / MP-02-2027-13785
- Keywords
- CADx, Computer-Aided Diagnosis, Optical Diagnosis, Colonoscopy, Diminutive Colorectal Polyps, Colorectal Adenoma, GI Genius, Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 840 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 31 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates whether an artificial intelligence system (GI Genius, Medtronic), already approved by Health Canada, can help doctors accurately identify, in real time during colonoscopy, which small colorectal polyps (5 mm or less) need to be monitored (adenomas) versus those that do not (for example, hyperplastic polyps). For each small polyp found, the endoscopist will first record a diagnosis without the help of the artificial intelligence system, then activate the system and record a second diagnosis after seeing its assessment. Both diagnoses will be compared to the final result from standard pathology testing, which remains the reference standard. This is an observational diagnostic accuracy study: it does not change any clinical care. All polyps continue to be removed and sent for pathology analysis as usual, whether or not the artificial intelligence system agrees with the doctor. The study will take place during colonoscopies already scheduled for standard clinical reasons (screening, surveillance, or diagnostic work-up), with no additional visits, blood draws, imaging, or sedation. Approximately 840 participants will be enrolled across three Canadian centres (Santé Québec - CHUM, McGill University Health Centre, and St. Paul's Hospital, Vancouver). The goal is to determine whether this AI-assisted approach helps doctors reach the internationally recognized performance thresholds (at least 80% sensitivity and 80% specificity) needed to support clinical adoption of real-time optical diagnosis, which could eventually reduce unnecessary pathology testing.
Detailed description
Colonoscopy with polypectomy is the cornerstone of colorectal cancer (CRC) screening and prevention. The majority of polyps detected during colonoscopy are diminutive (≤5 mm) and carry a very low risk of harbouring advanced pathology. In Canada, over 1.9 million colonoscopies are performed annually, and sending all diminutive polyps for histopathological examination (at a cost of approximately $150-$300 CAD per specimen) generates a substantial economic burden with limited benefit for cancer prevention.
Two international guideline frameworks define the performance thresholds required for clinical adoption of optical diagnosis strategies for diminutive colorectal polyps. The ASGE PIVI initiative (2011) established (1) ≥90% negative predictive value (NPV) for adenomatous histology among diminutive rectosigmoid polyps diagnosed with high confidence ("diagnose-and-leave" threshold), and (2) ≥90% agreement between optical-diagnosis-based and pathology-based post-polypectomy surveillance intervals ("resect-and-discard" threshold). The more recent ESGE SODA position statement (2022) adopted sensitivity and specificity as the foundational, prevalence-independent performance measures for high-confidence real-time characterization of colorectal neoplasia, applicable across all colonic locations: sensitivity ≥90% and specificity ≥80% for the rectosigmoid subset, and sensitivity ≥80% and specificity ≥80% across all diminutive colorectal polyps regardless of location.
The investigators' research group has previously conducted several single-centre studies evaluating early-generation, Health Canada-approved computer-aided diagnosis (CADx) systems in routine clinical practice, generating one of the largest real-world CADx implementation datasets in the literature (868 patients, 1,660 diminutive polyps). These studies consistently demonstrated suboptimal overall diagnostic accuracy (62.7%-66.4%), attributable to restricted training datasets and limited polyp-classification capabilities in early-generation devices. GI Genius (Medtronic), the newer-generation, Health Canada-approved CADx module evaluated in this study, was trained on a larger and more diverse dataset of annotated endoscopic images and videos. Whether this translates into measurable gains in diagnostic performance sufficient to meet international competence thresholds has not been established in an independent, prospective, multicentre study, and is the question this study addresses.
This is a prospective, three-centre diagnostic accuracy study conducted in accordance with the Standards for Reporting Diagnostic Accuracy Studies (STARD 2015). It is a single-arm study validating a CADx-assisted optical-diagnosis strategy - rather than autonomous or standalone CADx performance - in which the endoscopist's final CADx-assisted optical diagnosis constitutes the primary index test. For each diminutive polyp (≤5 mm) identified during an already-scheduled elective colonoscopy, the following sequential steps are performed: (1) the endoscopist records a CADx-unassisted optical diagnosis (adenoma, hyperplastic polyp, or other) and confidence level (high or low), which is electronically locked before any device output is viewed; (2) the CADx module is activated and displays its own characterization of the polyp; (3) the endoscopist records a final CADx-assisted optical diagnosis and confidence level, remaining free to agree or disagree with the device; (4) a research assistant documents polyp size, morphology (Paris classification), and colonic location; and (5) the polyp is resected per standard technique and sent for histopathological examination, which serves as the reference standard. This sequential-locking design - recording and locking the unassisted diagnosis before CADx activation - is the study's key strategy for minimizing contamination bias between the two diagnostic strategies, and allows each polyp to generate two paired diagnostic data points (CADx-unassisted and CADx-assisted) compared against a single histopathological reference standard.
The study will enroll consecutive patients aged 45-80 years undergoing elective colonoscopy (screening, surveillance, or diagnostic indication) at three Canadian academic centres: Santé Québec - CHUM (Montreal), the McGill University Health Centre (MUHC/CUSM, Montreal), and St. Paul's Hospital (Vancouver), who provide written informed consent before the colonoscopy and before sedation.
Inclusion criteria: signed informed consent obtained before the colonoscopy and before sedation; age 45-80 years; indication for elective colonoscopy (screening, surveillance, or diagnostic); and at least one diminutive polyp (≤5 mm) detected during the procedure, which is required for inclusion in the analytic cohort (consented patients in whom no eligible polyp is detected are documented as screen failures and do not contribute to the primary analysis).
Exclusion criteria: known inflammatory bowel disease; active colitis; coagulopathy or thrombocytopenia (INR ≥1.5 or platelets <50×10⁹/L); familial polyposis syndrome; American Society of Anesthesiologists (ASA) classification >III; emergency colonoscopy; and inadequate bowel preparation (Boston Bowel Preparation Scale <6).
All staff gastroenterologists and gastroenterology trainees performing elective colonoscopies at participating centres are eligible to participate as endoscopists, with no additional optical-diagnosis training provided, reflecting real-world implementation conditions.
The primary objective is to determine the sensitivity and specificity of CADx-assisted optical diagnosis for adenomatous histology among all diminutive colorectal polyps, benchmarked against the ESGE SODA competence thresholds (sensitivity ≥80%, specificity ≥80%), using histopathology as the reference standard. Secondary objectives include: the NPV of CADx-assisted diagnosis among high-confidence diminutive rectosigmoid polyps (ASGE PIVI threshold ≥90%); agreement between CADx-assisted and pathology-based surveillance interval recommendations (ASGE PIVI threshold ≥90%); sensitivity and specificity for the rectosigmoid subset (ESGE SODA threshold: sensitivity ≥90%, specificity ≥80%); a paired comparison of CADx-assisted versus CADx-unassisted diagnostic performance; diagnostic confidence calibration; and the proportion of CADx-assisted diagnoses made with high confidence. Prespecified exploratory subgroup analyses will evaluate diagnostic performance by polyp size (≤3 mm vs. 4-5 mm), morphology, colonic location, endoscopist experience level, patient biological sex, and study centre. A tertiary/exploratory objective is an integrated health economic evaluation - combining a decision tree and a state-transition Markov model, from both health-system and societal perspectives - assessing the cost-effectiveness of a possible future CADx-assisted "resect-and-discard"/"diagnose-and-leave" strategy compared with universal histopathological examination, with results reported per the CHEERS 2022 checklist.
A minimum of 826 patients is required to evaluate both co-primary outcomes (sensitivity and specificity) with an overall power of 80%, accounting for intra-patient clustering of polyps (design effect 1.3, based on an average of 1.91 diminutive polyps per patient and an intraclass correlation of 0.3). A recruitment target of 840 patients (approximately 1,605 diminutive polyps), enrolled evenly across the three centres (280 per centre) over an expected 24-month recruitment period, has been set to exceed this minimum. Sensitivity and specificity will be estimated using generalized linear mixed models with a logit link and a random effect for patient, to account for clustering of polyps within patients; each one-sided hypothesis test (H₀: sensitivity or specificity ≤80%) will be conducted at α=0.025, with study success requiring rejection of both null hypotheses. Prespecified sensitivity analyses include a per-protocol analysis, a high-confidence-only analysis aligned with formal ESGE SODA competence assessment, a reclassification of serrated lesions as neoplastic, models incorporating a random effect for endoscopist, and a temporal analysis for learning-curve or fatigue effects. No interim analyses are planned; all analyses will be conducted after complete enrolment.
There is no increased risk to participants beyond the standard risks of colonoscopy, since all polyps are resected according to usual clinical practice regardless of study participation, and no additional procedures (blood sampling, imaging, additional sedation, or follow-up visits) are performed for research purposes. This is an investigator-initiated study (Sponsor-Investigator: Dr. Daniel von Renteln, CHUM/CRCHUM); Medtronic Canada provides the GI Genius CADx equipment on loan for the study period, together with related installation and technical support only, and has no role in study design, recruitment, data collection, endpoint adjudication, statistical analysis, interpretation, or publication decisions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diminutive Colorectal Polyps - CADx-Assisted Optical Diagnosis | – | Device: GI Genius CADx module (Medtronic)Consecutive patients aged 45-80 undergoing elective colonoscopy (screening, surveillance, or diagnostic) at CHUM, CUSM, and St. Paul's Hospital who provide written informed consent before the colonoscopy and before sedation, and in whom at least one diminutive polyp (≤5 mm) is detected during the procedure. For each diminutive polyp, the endoscopist first records a CADx-unassisted optical diagnosis and confidence level (electronically locked before device activation), then activates the GI Genius CADx module, and records a final CADx-assisted optical diagnosis and confidence level after viewing the device-provided characterization. All polyps are resected and sent for histopathological examination, which serves as the reference standard. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients aged 45-80 years undergoing elective colonoscopy (screening, surveillance, or diagnostic) at three Canadian academic centres (CHUM, CUSM, St. Paul's Hospital), providing written informed consent before the procedure and before sedation. Patients become eligible for the analytic cohort if at least one diminutive polyp (≤5 mm) is detected during colonoscopy; those without an eligible polyp are recorded as screen failures. Key exclusions: inflammatory bowel disease, active colitis, coagulopathy/thrombocytopenia, familial polyposis syndrome, ASA >III, emergency colonoscopy, or inadequate bowel preparation. Target: 840 patients (~1,605 diminutive polyps) across the three centres over 24 months.
Key inclusion criteria (4 listed)
- Signed informed consent, obtained before the colonoscopy and before sedation
- Age 45-80 years
- Indication for elective colonoscopy (screening, surveillance, or diagnostic)
- At least one diminutive polyp (≤5 mm) detected during the procedure (required for inclusion in the analytic cohort; consented patients without an eligible polyp are documented as screen failures)
Key exclusion criteria (7 listed)
- Known inflammatory bowel disease
- Active colitis
- Coagulopathy or thrombocytopenia (INR ≥1.5 or platelets <50×10⁹/L)
- Familial polyposis syndrome
- American Society of Anesthesiologists classification >III
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GI Genius CADx module (Medtronic)Computer-aided diagnosis (CADx) device recently approved by Health Canada, used to provide real-time optical characterization of diminutive colorectal polyps (≤5 mm) during colonoscopy. For each diminutive polyp detected, the endoscopist first records a CADx-unassisted optical diagnosis (electronically locked before device activation), then activates the GI Genius CADx module, which displays a device-provided characterization. The endoscopist then records a final CADx-assisted optical diagnosis, which may agree or disagree with the device output. The study evaluates the CADx-assisted optical-diagnosis strategy (endoscopist + device combined) rather than autonomous or standalone CADx performance. | Device | Diminutive Colorectal Polyps - CADx-Assisted Optical Diagnosis |
Primary outcome
Sensitivity of CADx-assisted optical diagnosis for adenomatous histology
Time frame: Within 14 to 45 days after polypectomy (colorectal polyp resection during the index colonoscopy), once histopathology results are available
Number of correct adenomatous optical diagnoses divided by the number of histologically confirmed adenomas, among all diminutive (≤5 mm) colorectal polyps, benchmarked against the ESGE SODA threshold (≥80%)
Specificity of CADx-assisted optical diagnosis for adenomatous histology
Time frame: Within 14 to 45 days after polypectomy (colorectal polyp resection during the index colonoscopy), once histopathology results are available
Number of correct non-adenomatous optical diagnoses divided by the number of histologically confirmed non-adenomas, among all diminutive (≤5 mm) colorectal polyps, benchmarked against the ESGE SODA threshold (≥80%)
6 secondary outcomes
NPV of CADx-assisted optical diagnosis for adenomatous histology (rectosigmoid, high confidence)
Time frame: Within 14 to 45 days after polypectomy (colorectal polyp resection during the index colonoscopy), once histopathology results are available
Surveillance interval agreement
Time frame: Outcome assessed throughout the 24-month recruitment period, with total study duration of 36 months
Sensitivity and specificity, rectosigmoid subset
Time frame: Outcome assessed throughout the 24-month recruitment period, with total study duration of 36 months
CADx-assisted vs. CADx-unassisted diagnostic performance
Time frame: Outcome assessed throughout the 24-month recruitment period, with total study duration of 36 months
High-confidence prediction rate
Time frame: Outcome assessed throughout the 24-month recruitment period, with total study duration of 36 months
Confidence calibration
Time frame: Outcome assessed throughout the 24-month recruitment period, with total study duration of 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Background: PubMed 32598963Hassan C, Spadaccini M, Iannone A, Maselli R, Jovani M, Chandrasekar VT, Antonelli G, Yu H, Areia M, Dinis-Ribeiro M, Bhandari P, Sharma P, Rex DK, Rosch T, Wallace M, Repici A. Performance of artificial intelligence in colonoscopy for adenoma and polyp detection: a systematic review and meta-analysis. Gastrointest Endosc. 2021 Jan;93(1):77-85.e6. doi: 10.1016/j.gie.2020.06.059. Epub 2020 Jun 26.
- Background: PubMed 35773468Biffi C, Salvagnini P, Dinh NN, Hassan C, Sharma P; GI Genius CADx Study Group; Cherubini A. A novel AI device for real-time optical characterization of colorectal polyps. NPJ Digit Med. 2022 Jun 30;5(1):84. doi: 10.1038/s41746-022-00633-6.
- Background: PubMed 29066576Byrne MF, Chapados N, Soudan F, Oertel C, Linares Perez M, Kelly R, Iqbal N, Chandelier F, Rex DK. Real-time differentiation of adenomatous and hyperplastic diminutive colorectal polyps during analysis of unaltered videos of standard colonoscopy using a deep learning model. Gut. 2019 Jan;68(1):94-100. doi: 10.1136/gutjnl-2017-314547. Epub 2017 Oct 24.
- Background: PubMed 30105375Mori Y, Kudo SE, Misawa M, Saito Y, Ikematsu H, Hotta K, Ohtsuka K, Urushibara F, Kataoka S, Ogawa Y, Maeda Y, Takeda K, Nakamura H, Ichimasa K, Kudo T, Hayashi T, Wakamura K, Ishida F, Inoue H, Itoh H, Oda M, Mori K. Real-Time Use of Artificial Intelligence in Identification of Diminutive Polyps During Colonoscopy: A Prospective Study. Ann Intern Med. 2018 Sep 18;169(6):357-366. doi: 10.7326/M18-0249. Epub 2018 Aug 14.
- Background: PubMed 35017145Husereau D, Drummond M, Augustovski F, de Bekker-Grob E, Briggs AH, Carswell C, Caulley L, Chaiyakunapruk N, Greenberg D, Loder E, Mauskopf J, Mullins CD, Petrou S, Pwu RF, Staniszewska S; CHEERS 2022 ISPOR Good Research Practices Task Force. Consolidated Health Economic Evaluation Reporting Standards 2022 (CHEERS 2022) statement: updated reporting guidance for health economic evaluations. BMJ. 2022 Jan 11;376:e067975. doi: 10.1136/bmj-2021-067975.
- Background: PubMed 20621680Hassan C, Pickhardt PJ, Rex DK. A resect and discard strategy would improve cost-effectiveness of colorectal cancer screening. Clin Gastroenterol Hepatol. 2010 Oct;8(10):865-9, 869.e1-3. doi: 10.1016/j.cgh.2010.05.018. Epub 2010 Jun 1.
- Background: PubMed 38331204Djinbachian R, Haumesser C, Taghiakbari M, Pohl H, Barkun A, Sidani S, Liu Chen Kiow J, Panzini B, Bouchard S, Deslandres E, Alj A, von Renteln D. Autonomous Artificial Intelligence vs Artificial Intelligence-Assisted Human Optical Diagnosis of Colorectal Polyps: A Randomized Controlled Trial. Gastroenterology. 2024 Jul;167(2):392-399.e2. doi: 10.1053/j.gastro.2024.01.044. Epub 2024 Feb 7.
- Background: PubMed 26511519Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig L, Lijmer JG, Moher D, Rennie D, de Vet HC, Kressel HY, Rifai N, Golub RM, Altman DG, Hooft L, Korevaar DA, Cohen JF; STARD Group. STARD 2015: an updated list of essential items for reporting diagnostic accuracy studies. BMJ. 2015 Oct 28;351:h5527. doi: 10.1136/bmj.h5527.
- Background: PubMed 32882737Dekker E, Houwen BBSL, Puig I, Bustamante-Balen M, Coron E, Dobru DE, Kuvaev R, Neumann H, Johnson G, Pimentel-Nunes P, Sanders DS, Dinis-Ribeiro M, Arvanitakis M, Ponchon T, East JE, Bisschops R. Curriculum for optical diagnosis training in Europe: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement. Endoscopy. 2020 Oct;52(10):899-923. doi: 10.1055/a-1231-5123. Epub 2020 Sep 3.
- Background: PubMed 34872120Houwen BBSL, Hassan C, Coupe VMH, Greuter MJE, Hazewinkel Y, Vleugels JLA, Antonelli G, Bustamante-Balen M, Coron E, Cortas GA, Dinis-Ribeiro M, Dobru DE, East JE, Iacucci M, Jover R, Kuvaev R, Neumann H, Pellise M, Puig I, Rutter MD, Saunders B, Tate DJ, Mori Y, Longcroft-Wheaton G, Bisschops R, Dekker E. Definition of competence standards for optical diagnosis of diminutive colorectal polyps: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement. Endoscopy. 2022 Jan;54(1):88-99. doi: 10.1055/a-1689-5130. Epub 2021 Dec 6.
- Background: PubMed 25597420ASGE Technology Committee; Abu Dayyeh BK, Thosani N, Konda V, Wallace MB, Rex DK, Chauhan SS, Hwang JH, Komanduri S, Manfredi M, Maple JT, Murad FM, Siddiqui UD, Banerjee S. ASGE Technology Committee systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting real-time endoscopic assessment of the histology of diminutive colorectal polyps. Gastrointest Endosc. 2015 Mar;81(3):502.e1-502.e16. doi: 10.1016/j.gie.2014.12.022. Epub 2015 Jan 16.
- Background: PubMed 21353837Rex DK, Kahi C, O'Brien M, Levin TR, Pohl H, Rastogi A, Burgart L, Imperiale T, Ladabaum U, Cohen J, Lieberman DA. The American Society for Gastrointestinal Endoscopy PIVI (Preservation and Incorporation of Valuable Endoscopic Innovations) on real-time endoscopic assessment of the histology of diminutive colorectal polyps. Gastrointest Endosc. 2011 Mar;73(3):419-22. doi: 10.1016/j.gie.2011.01.023.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data collected in this study will not be made publicly available. Patient data are coded and stored securely in compliance with institutional privacy policies at all three participating sites (CHUM, CUSM, St. Paul's Hospital). While the protocol allows for retention of study data for future research purposes (e.g., further characterization of polyp features or continued AI model development), this secondary use is limited to the study's own research team and governed by the original research ethics board approval, rather than through open public sharing of individual-level data. No data-sharing repository, external access mechanism, or de-identification/sharing procedure for external investigators is specified in the protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel von Renteln, Doctor of Medicine (MD), Gastr contact
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Polyps and Colorectal Adenoma, run by Centre hospitalier de l'Université de Montréal (CHUM).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel von Renteln, Doctor of Medicine (MD), Gastr (514-890-8000 ext. 30912, daniel.von.renteln.med@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of CADx-assisted optical diagnosis for adenomatous histology (time frame: Within 14 to 45 days after polypectomy (colorectal polyp resection during the index colonoscopy), once histopathology results are available). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07738484, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.