Colorectal PolypNCT05236790
Evaluation of CAD-EYE/SCALE-EYE for Detection, Classification, and Measurement of Colorectal Polyps: a Prospective Study
A study testing Detection and classification and size measurement of polyp by Artificial Intelligence (Cad eye) and the Scale Eye in people with Colorectal Polyp and Colorectal Adenoma, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
The investigators hypothesize that the clinical implementation of an AI system is an optimal tool to monitor, audit and improve the detection and classification of polyps during colonoscopy. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Colorectal Polyp, Colorectal Adenoma
- What is being tested?
- Detection and classification and size measurement of polyp by Artificial Intelligence (Cad eye) and the Scale Eye
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jun 2022to 20 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- indication of undergoing a screening, surveillance, or diagnostic colonoscopy
- Age 45-80 years
- Signed informed consent
Who cannot join
- Known inflammatory bowel disease (IBD)
- Active Colitis
- Poor general health, defined as an American Society of Anesthesiologists (ASA) physical status class >3
- Coagulopathy
- Familial polyposis syndrome
- Emergency colonoscopies
Show all 11Show fewer
- Poor bowel preparation score defined as the total Boston bowel preparation score <6 and the right-segment score <2.
- For per-polyp analysis:
- For optical diagnosis (CADx) we will exclude all polyps >5mm. We will also exclude sessile serrated polyps and traditional serrated adenomas from the analysis as CADx can only differentiate between adenomas and hyperplastic polyps.
- For polyp size measurement (SCALE-EYE), we will exclude all polyps resected in several pieces (piecemeal resection), or specimens damaged (e.g., fractured) during the suction and retrieval process, submillimeter polyps too small for measurement after resection. Polyps after the 5th resected polyp in a single piece will be excluded to reduce the time associated with the procedure.
- For polyp detection (CADe) we will not exclude any polyp from the analysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Performance Evaluation of CAD-EYE and SCALE-EYE for Detection, Classification, and Measurement of Colorectal Polyps: a Prospective Study
The investigators hypothesize that the clinical implementation of an AI system is an optimal tool to monitor, audit and improve the detection and classification of polyps during colonoscopy. The purpose of this prospective clinical cohort study is to evaluate the performance of the SCALE-EYE virtual scale for measuring polyp size when used during live colonoscopies. The investigators also wish to evaluate CAD-eye for detection and classification of polyp histology. It is hypothesized that CAD-eye and SCALE-EYE can function in real-time practice with high accuracy.
Read the detailed description
Detailed Description:
This study will be conducted in several phases: phase 1 will evaluate the feasibility of using CAD-eye in real-time practice, training endoscopists to work with this platform, obtaining preliminary data on relative size measurement accuracy when using scale eye, testing feasibility of fresh polyp specimen size measurement and determining the sample size and reference standard for evaluating SCALE-EYE during the subsequent phases of the study in randomized controlled trials. Phase 2 will evaluate relative size measurement accuracy of SCALE-EYE compared to visual size estimation and CADe/CADx performance in a randomized controlled trial. Scale-eye will further be validated through video-based analysis comparing different size measurement methods (scale eye, snare, forceps, visual assessment) with different groups of endoscopists (experts, staff gastroenterologists, trainees evaluating videos showing video sequences that show the polyps either with scale eye, visual or instrument information. Furthermore, fresh specimen size measurement and pathology-based size (including different ways to prepare specimens for pathology sectioning) will be evaluated for agreement between size measurement methods and tissue shrinkage effects. Phase 3 will evaluate relative size measurement accuracy of SCALE-EYE compared to snare-based size estimation.
Eligible patients will be adults (aged 45 to 80 years) referred to CHUM for diagnostic, screening or surveillance colonoscopy. Patients will undergo colonoscopies using CAD-eye, and the size of all polyps detected will be estimated by different subjective and objective methods. All polyp size measurements will be videorecorded. Video recordings with different measurement instruments (forceps, snare, scale eye, visual assessment) will be assessed with different groups of endoscopists (experts, staff gastroenterologists, trainees) for size measurements through online video presentations in a randomized order. The main results of this study are to evaluate the relative accuracy of SCALE-EYE for polyp size estimation and the adenoma detection rates, sensitivity, specificity, NPV for CAD-eye for polyp detection and classification. We will also calculate other characteristics of CAD-eye and SCALE-EYE tests, the rate of divergence and/or agreement between subjective and objective methods of polyp size estimation, the agreement between surveillance intervals based on optical diagnosis by CAD-eye and pathological findings, and the false positive rate and latency for polyp detection.
- Conditions
- Colorectal Polyp, Colorectal Adenoma
- Being tested
- Detection and classification and size measurement of polyp by Artificial Intelligence (Cad eye) and the Scale Eye
- Keywords
- Polyps detection, Adenoma detection, Polyps classification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection and classification and size measurement of polyp by Artificial Intelligence (Cad eye) and the Scale EyeDiagnostic test
Detection and classification and size measurement of polyp by Artificial Intelligence (CADeye) and Scale Eye This study will be conducted in multiple phases: phase 1 (pilot phase, n=40 polyps, about 60 patients) to evaluate the feasibility of applying Scale Eye in real-time practice, training endoscopists to work with CADe and CADx and determining the sample size and reference standard to evaluate SCALE-EYE during the second phase of the study (randomized controlled trial), phase 2 will evaluate the performance of SCALE-EYE and CAD-eye in real-time practice. The sample size for phase 2 (RCT comparing visual with scasle eye) will be based on the pilot data allowing to compare relative accuracy of size measurement with scale eye versus visual size estimation. After completion of phase 2 later phases will use instruments such as snare and/or forceps as reference measurement devices compared to relative accuracy of measurement when using scale eye.
| Study group | Role | What they receive |
|---|---|---|
| Artificial intelligence for real-time detection and monitoring of colorectal polyps | Experimental | Colonoscopies will be performed according to the standard of care. Patients will undergo colonoscopies using CAD-eye (CADe and CADx) and Scale-eye. All optically diagnosed (CADx) polyps will be removed and sent to the CHUM pathology laboratory for histopathological evaluation according to institutional standards. CADx will be combined with human input for final diagnosis. Receives: Diagnostic Test: Detection and classification and size measurement of polyp by Artificial Intelligence (Cad eye) and the Scale Eye |
| Real time polyp detection using a standard colonoscopy without CAD eye | No intervention | Real time polyp detection using a standard colonoscopy without CAD eye and without CADe. Patients will undergo a standard colonoscopy. Polyp size measurement will be assessed visually (phase 1 and 2) or with instruments such as snare or forceps (phase 3 or later) and polyp classification will be done by CADx without further input by the endoscopist. All optically diagnosed polyps will be removed and sent to the CHUM pathology laboratory for histopathological evaluation according to institutional standards. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the Scale-Eye
to compare the relative accuracies of SCALE-EYE size measurement, visual size estimation or size estimation based on a standard polypectomy snare for colorectal polyps during real-time colonoscopies with measurement of viable specimens by a Vernier caliper as reference standard. Relative accuracy is defined as "1-[(ScaleEye measurement - gold standard measurement)/gold standard measurement] x100". Scale: 0-100. Higher score is a better outcome.
Measured: 30 days
Evaluation of CADe function
compare the adenoma detection rate between the CAD-eye-assisted colonoscopy and standard colonoscopy (i.e., detecting adenomas only by endoscopists)
Measured: 30 days
Evaluation of CADx function
evaluate the accuracy, sensitivity, specificity, positive and negative predictive value of CADx for classifying 1-5 mm polyp histology into neoplastic and non-neoplastic compared with the histopathology outcomes as the reference standard
Measured: 30 days
Secondary outcomes (9)
Agreement and discrepancy between SCALE-EYE and other measurement
calculate the agreement and discrepancy between SCALE-EYE and other measurement methods
Measured: 30 days
Video-based assessments
compare in video-based assessments with different endoscopists (expert level, staff GI, surgeons, trainees the relative size measurements accuracy of scale eye with visual and instrument based (snare and/or forceps) size measurement accuracy
Measured: 30 days
CADe sensitivity in polyp detection
evaluate the sensitivity of the CAD-eye in combination with adjunct methods for real-time detecting colorectal polyps compared with standard colonoscopy
Measured: 30 days
CADe function: proportion of polyps detected
to evaluate the proportion of polyps detected by the CAD-eye in combination with adjunct methods
Measured: 30 days
Evaluation of CADx function
compare the accuracy, sensitivity, specificity, positive and negative predictive value of CADx for classifying 1-5 mm polyp histology to that of using human decision based on CADx suggestion
Measured: Through study completion, estimation: 3 months
CADx proportion of polyp histology non-evaluable
calculate the proportion of 1-5 mm polyps, CADx can not suggest histology (in the intervention arm, please refer to the randomization section), while endoscopists can suggest histology with high confidence, or vice versa
Measured: 30 days
CADx diagnostic uncertainty
evaluate diagnostic uncertainty of the current CADx module when predicting the pathology of colorectal polyps
Measured: 30 days
3D scanning assessment
evaluation of the relative accuracy of 3D scanned polyps compared to measurement of viable specimens by a Vernier caliper as reference standard. Relative accuracy is defined as "1-[(ScaleEye measurement - gold standard measurement)/gold standard measurement] x100". Scale: 0-100. Higher score is a better outcome.
Measured: 30 days
Histologic size assessment
evaluation of the relative accuracy of histologic size measurement compared to measurement of viable specimens by a Vernier caliper as reference standard. Relative accuracy is defined as "1-[(ScaleEye measurement - gold standard measurement)/gold standard measurement] x100". Scale: 0-100. Higher score is a better outcome.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start20 Jun 2022
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal PolypStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- prospective, multi-endoscopist, single center
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel von Renteln, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236790
- Sponsor's protocol ID
- 21.305
- Status last verified
- Sep 2023
- First submitted
- 2 Feb 2022
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Djinbachian 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 38331204Taghiakbari M, Djinbachian R, Haumesser C, Sidani S, Chen Kiow JL, Panzini B, von Renteln D. Measuring Size of Colorectal Polyps Using a Virtual Scale Endoscope or Visual Assessment: A Randomized Controlled Trial. Am J Gastroenterol. 2024 Jul 1;119(7):1309-1317. doi: 10.14309/ajg.0000000000002623. Epub 2023 Dec 12.
PubMed 38084850
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation of CAD-EYE and SCALE-EYE for Detection, Classification, and Measurement of Colorectal Polyps: a Prospective Study
- ClinicalTrials.gov ID
- NCT05236790
- Acronym / sponsor ID
- 21.305
- Conditions
- Colorectal Polyp, Colorectal Adenoma
- Keywords
- Polyps detection, Adenoma detection, Polyps classification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 11 Feb 2022 (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.
The investigators hypothesize that the clinical implementation of an AI system is an optimal tool to monitor, audit and improve the detection and classification of polyps during colonoscopy. The purpose of this prospective clinical cohort study is to evaluate the performance of the SCALE-EYE virtual scale for measuring polyp size when used during live colonoscopies. The investigators also wish to evaluate CAD-eye for detection and classification of polyp histology. It is hypothesized that CAD-eye and SCALE-EYE can function in real-time practice with high accuracy.
Detailed description
Detailed Description:
This study will be conducted in several phases: phase 1 will evaluate the feasibility of using CAD-eye in real-time practice, training endoscopists to work with this platform, obtaining preliminary data on relative size measurement accuracy when using scale eye, testing feasibility of fresh polyp specimen size measurement and determining the sample size and reference standard for evaluating SCALE-EYE during the subsequent phases of the study in randomized controlled trials. Phase 2 will evaluate relative size measurement accuracy of SCALE-EYE compared to visual size estimation and CADe/CADx performance in a randomized controlled trial. Scale-eye will further be validated through video-based analysis comparing different size measurement methods (scale eye, snare, forceps, visual assessment) with different groups of endoscopists (experts, staff gastroenterologists, trainees evaluating videos showing video sequences that show the polyps either with scale eye, visual or instrument information. Furthermore, fresh specimen size measurement and pathology-based size (including different ways to prepare specimens for pathology sectioning) will be evaluated for agreement between size measurement methods and tissue shrinkage effects. Phase 3 will evaluate relative size measurement accuracy of SCALE-EYE compared to snare-based size estimation.
Eligible patients will be adults (aged 45 to 80 years) referred to CHUM for diagnostic, screening or surveillance colonoscopy. Patients will undergo colonoscopies using CAD-eye, and the size of all polyps detected will be estimated by different subjective and objective methods. All polyp size measurements will be videorecorded. Video recordings with different measurement instruments (forceps, snare, scale eye, visual assessment) will be assessed with different groups of endoscopists (experts, staff gastroenterologists, trainees) for size measurements through online video presentations in a randomized order. The main results of this study are to evaluate the relative accuracy of SCALE-EYE for polyp size estimation and the adenoma detection rates, sensitivity, specificity, NPV for CAD-eye for polyp detection and classification. We will also calculate other characteristics of CAD-eye and SCALE-EYE tests, the rate of divergence and/or agreement between subjective and objective methods of polyp size estimation, the agreement between surveillance intervals based on optical diagnosis by CAD-eye and pathological findings, and the false positive rate and latency for polyp detection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- prospective, multi-endoscopist, single center
| Arm | Type | Receives |
|---|---|---|
| Artificial intelligence for real-time detection and monitoring of colorectal polyps | Experimental | Diagnostic Test: Detection and classification and size measurement of polyp by Artificial Intelligence (Cad eye) and the Scale EyeColonoscopies will be performed according to the standard of care. Patients will undergo colonoscopies using CAD-eye (CADe and CADx) and Scale-eye. All optically diagnosed (CADx) polyps will be removed and sent to the CHUM pathology laboratory for histopathological evaluation according to institutional standards. CADx will be combined with human input for final diagnosis. |
| Real time polyp detection using a standard colonoscopy without CAD eye | No intervention | –Real time polyp detection using a standard colonoscopy without CAD eye and without CADe. Patients will undergo a standard colonoscopy. Polyp size measurement will be assessed visually (phase 1 and 2) or with instruments such as snare or forceps (phase 3 or later) and polyp classification will be done by CADx without further input by the endoscopist. All optically diagnosed polyps will be removed and sent to the CHUM pathology laboratory for histopathological evaluation according to institutional standards. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- indication of undergoing a screening, surveillance, or diagnostic colonoscopy
- Age 45-80 years
- Signed informed consent
Key exclusion criteria (11 listed)
- Known inflammatory bowel disease (IBD)
- Active Colitis
- Poor general health, defined as an American Society of Anesthesiologists (ASA) physical status class >3
- Coagulopathy
- Familial polyposis syndrome
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 |
|---|---|---|
| Detection and classification and size measurement of polyp by Artificial Intelligence (Cad eye) and the Scale EyeDetection and classification and size measurement of polyp by Artificial Intelligence (CADeye) and Scale Eye This study will be conducted in multiple phases: phase 1 (pilot phase, n=40 polyps, about 60 patients) to evaluate the feasibility of applying Scale Eye in real-time practice, training endoscopists to work with CADe and CADx and determining the sample size and reference standard to evaluate SCALE-EYE during the second phase of the study (randomized controlled trial), phase 2 will evaluate the performance of SCALE-EYE and CAD-eye in real-time practice. The sample size for phase 2 (RCT comparing visual with scasle eye) will be based on the pilot data allowing to compare relative accuracy of size measurement with scale eye versus visual size estimation. After completion of phase 2 later phases will use instruments such as snare and/or forceps as reference measurement devices compared to relative accuracy of measurement when using scale eye. | Diagnostic test | Artificial intelligence for real-time detection and monitoring of colorectal polyps |
Primary outcome
Evaluation of the Scale-Eye
Time frame: 30 days
to compare the relative accuracies of SCALE-EYE size measurement, visual size estimation or size estimation based on a standard polypectomy snare for colorectal polyps during real-time colonoscopies with measurement of viable specimens by a Vernier caliper as reference standard. Relative accuracy is defined as "1-[(ScaleEye measurement - gold standard measurement)/gold standard measurement] x100". Scale: 0-100. Higher score is a better outcome.
Evaluation of CADe function
Time frame: 30 days
compare the adenoma detection rate between the CAD-eye-assisted colonoscopy and standard colonoscopy (i.e., detecting adenomas only by endoscopists)
Evaluation of CADx function
Time frame: 30 days
evaluate the accuracy, sensitivity, specificity, positive and negative predictive value of CADx for classifying 1-5 mm polyp histology into neoplastic and non-neoplastic compared with the histopathology outcomes as the reference standard
9 secondary outcomes
Agreement and discrepancy between SCALE-EYE and other measurement
Time frame: 30 days
Video-based assessments
Time frame: 30 days
CADe sensitivity in polyp detection
Time frame: 30 days
CADe function: proportion of polyps detected
Time frame: 30 days
Evaluation of CADx function
Time frame: Through study completion, estimation: 3 months
CADx proportion of polyp histology non-evaluable
Time frame: 30 days
CADx diagnostic uncertainty
Time frame: 30 days
3D scanning assessment
Time frame: 30 days
Histologic size assessment
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Derived from this study: 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.
- Derived from this study: PubMed 38084850Taghiakbari M, Djinbachian R, Haumesser C, Sidani S, Chen Kiow JL, Panzini B, von Renteln D. Measuring Size of Colorectal Polyps Using a Virtual Scale Endoscope or Visual Assessment: A Randomized Controlled Trial. Am J Gastroenterol. 2024 Jul 1;119(7):1309-1317. doi: 10.14309/ajg.0000000000002623. Epub 2023 Dec 12.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Daniel von Renteln principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Detection and classification and size measurement of polyp by Artificial Intelligence (Cad eye) and the Scale Eye in people with Colorectal Polyp and Colorectal Adenoma, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 3 inclusion and 11 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: finished, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the Scale-Eye (time frame: 30 days). The study lists 3 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 NCT05236790, which also lists 2 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 2 Oct 2023.