Artificial IntelligenceCAG-SIG-AINCT05244278
Artificial Intelligence (AI) Assisted Real-time Adenoma Detection and Classification During Colonoscopies
A study testing Medtronic-GI genius (CADe system for detecting colorectal polyps) in people with Artificial Intelligence, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial summary
This is a pragmatic, double-blind, randomized, controlled trial, to evaluate the effect of implementing a Computer-assisted detection (CADe) system within the routine clinical practice of Canadian healthcare institutions. Read more about this study
- Who is it for?
- Ages 45 to 89 years
- Conditions the study is for
- Artificial Intelligence
- What is being tested?
- Medtronic-GI genius (CADe system for detecting colorectal polyps)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,596 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2023to 1 Jan 2027
- Phase
- Interventional
- 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 89 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 45-89 years
Who cannot join
- Patients undergoing emergency colonoscopy
- Patients with a known familial polyposis syndrome or a known inflammatory bowel disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Montréal
Montreal, Quebec
Samira Hanin, 514-890-8000 ext. 30916, samira.hanin.chum@ssss.gouv.qc.ca
Daniel von Renteln, MD, PhD
About this study
This is a pragmatic, double-blind, randomized, controlled trial, to evaluate the effect of implementing a Computer-assisted detection (CADe) system within the routine clinical practice of Canadian healthcare institutions.
The main hypothesis of this study is that the ADR in the operating room equipped with the GI genius CADe system will be significantly higher than the ADR in the ordinary operating room.
Read the detailed description
This trial will be conducted in four centers across Canada. All patients who meet the in/exclusion criteria can be enrolled. The patient's personal medical history will be reviewed to verify patient inclusion and exclusion criteria (age, history of CRC or adenoma, comorbid conditions, anticoagulation, etc.).
Eligible patients will be randomized (1:1) stratified per center, endoscopist, sex, and age group in two arms:
- Intervention arm: patients will be assigned to undergo colonoscopy in a room equipped with the GI genius CADe system.
- Control arm: patients will undergo colonoscopy in a room not equipped with the GI genius CADe system.
The endoscopists performing the colonoscopies will not be involved in the development and implementation of CADe. Additionally, they won't be informed of the ongoing trial and will have the option of not using the CADe when available in the room. This design aims to mitigate operator biases that may be partly responsible for the observed difference between the CADe performance in randomized controlled trials and the CADe performance in implementation studies.
Data will be collected on case report forms (CRF), after the procedure, from the clinical files and the endoscopy reports. The data will then be deidentified and transferred to an electronic RedCap database in each institution. A research assistant will collect all information and annotations recorded on the patient's medical file during the procedure.
In the treatment group (operating room equipped with the CADe), the Medtronic-GI genius system can be used for real-time support by the endoscopists to detect polyps of all sizes. Use of CADe is left to the discretion of the treating physician performing the colonoscopy. If used, CADe will provide real-time feedback throughout each colonoscopy procedure and will alert the endoscopists of the presence of a polyp in the endoscopy field by displaying a bounding box on the same screen.
In the control group (colonoscopy performed in room without CADe system), the participating endoscopists will detect as per standard of care.
All colonoscopies (in the intervention and control groups) including polypectomy procedures will be performed at the discretion of the treating physician and per standard of care.
All polyps will be resected as per standard of care and sent to the pathology labs of the participating institutions to be evaluated for histology by board-certified pathologists. The histopathology outcomes will be collected and stored in the CRF forms to be used as a reference later.
- Conditions
- Artificial Intelligence
- Being tested
- Medtronic-GI genius (CADe system for detecting colorectal polyps)
- Keywords
- Polyp detection, Adenoma detection, Adenoma per colonoscopy, Sessile serrated lesion detection rate, Sessile serrated lesion per colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic-GI genius (CADe system for detecting colorectal polyps)Device
Medtronic-GI genius: AI will provide real-time feedback throughout each colonoscopy procedure and alert endoscopists to the presence of a polyp in the endoscopy field by displaying a bounding box on the same screen.
| Study group | Role | What they receive |
|---|---|---|
| Operating room equipped with the CADe (Medtronic-GI genius for real-time detection) | Experimental | The Medtronic-GI genius (CADe) system can be used to detect polyps of all sizes. Use of CADe is left to the discretion of the treating physician performing the colonoscopy. If used CADe will provide real-time feedback throughout each colonoscopy procedure and will alert the endoscopists of the presence of a polyp in the endoscopy field by displaying a bounding box on the same screen. Receives: Device: Medtronic-GI genius (CADe system for detecting colorectal polyps) |
| Colonoscopy performed in room without CADe system | No intervention | In the control group (standard colonoscopy), the participating endoscopists will detect and classify colorectal lesions without using any AI modules. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADR
The adenoma detection rate (ADR) is defined as the proportion of colonoscopies with at least 1 histopathologically proven adenoma or carcinoma detected.
Measured: 30 days
Secondary outcomes (7)
Mean number of adenomas per colonoscopy (APC)
Mean number of adenomas per colonoscopy (APC) defined as the total number of adenomas divided by the number of colonoscopies performed
Measured: 30 days
Sessile serrated lesions (SSL) detection rate
Sessile serrated lesions (SSL) detection rate as the proportion of patients colonoscopy in whom superior or equal to 1 sessile serrated lesion (SSL) is identified
Measured: 30 days
Sessile serrated lesion per Colonoscopy (SSLPC)
Sessile serrated lesion per Colonoscopy (SSLPC), defined as the total number of histologically confirmed sessile serrated lesions resected divided by the total number of colonoscopies
Measured: 30 days
Advanced lesion detection rate (ALDR)
Advanced lesion detection rate (ALDR), defined as the proportion of colonoscopies for which the number of histopathologically proven adenoma >10mm was at least 1.
Measured: 30 days
Proximal ADR
Proximal ADR is defined as the prevalence of patients with at least 1 adenoma detected proximal to the splenic flexure
Measured: 30 days
Proportion neoplastic and non-neoplastic polyps
Proportion neoplastic and non-neoplastic polyps (i.e., SSLs, hyperplastic polyps, and high-grade dysplasia and carcinomas (overall and according to size, location, and morphology)
Measured: 30 days
CADe utilization rate
CADe utilization rate (when available in the room). Since the CADe utilization rate cannot be assessed without revealing the ongoing trial to the endoscopists, two voluntary self-reported measures and a partially objective measure. First, endoscopists will be surveyed via email during and at the end of the trial regarding their use of CADe, while keeping them unaware of the ongoing trial. Second, the proportion with endoscopy reports for which is is explicitly stated that CADe was used will be computed.
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start1 Aug 2023
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Artificial IntelligenceStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- pragmatic double-blinded, randomized, multi-endoscopist, multicenter
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 1,596 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University, University of British Columbia, Université de Sherbrooke, University of Alberta
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244278
- Sponsor's protocol ID
- 2022-10312, 21.297
- Acronym
- CAG-SIG-AI
- Status last verified
- Sep 2026
- First submitted
- 8 Feb 2022
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence (AI) Assisted Real-time Adenoma Detection and Classification During Colonoscopies
- ClinicalTrials.gov ID
- NCT05244278
- Acronym / sponsor ID
- CAG-SIG-AI / 2022-10312, 21.297
- Conditions
- Artificial Intelligence
- Keywords
- Polyp detection, Adenoma detection, Adenoma per colonoscopy, Sessile serrated lesion detection rate, Sessile serrated lesion per colonoscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,596 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- McGill University, University of British Columbia, Université de Sherbrooke, University of Alberta
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 17 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.
This is a pragmatic, double-blind, randomized, controlled trial, to evaluate the effect of implementing a Computer-assisted detection (CADe) system within the routine clinical practice of Canadian healthcare institutions.
The main hypothesis of this study is that the ADR in the operating room equipped with the GI genius CADe system will be significantly higher than the ADR in the ordinary operating room.
Detailed description
This trial will be conducted in four centers across Canada. All patients who meet the in/exclusion criteria can be enrolled. The patient's personal medical history will be reviewed to verify patient inclusion and exclusion criteria (age, history of CRC or adenoma, comorbid conditions, anticoagulation, etc.).
Eligible patients will be randomized (1:1) stratified per center, endoscopist, sex, and age group in two arms:
- Intervention arm: patients will be assigned to undergo colonoscopy in a room equipped with the GI genius CADe system.
- Control arm: patients will undergo colonoscopy in a room not equipped with the GI genius CADe system.
The endoscopists performing the colonoscopies will not be involved in the development and implementation of CADe. Additionally, they won't be informed of the ongoing trial and will have the option of not using the CADe when available in the room. This design aims to mitigate operator biases that may be partly responsible for the observed difference between the CADe performance in randomized controlled trials and the CADe performance in implementation studies.
Data will be collected on case report forms (CRF), after the procedure, from the clinical files and the endoscopy reports. The data will then be deidentified and transferred to an electronic RedCap database in each institution. A research assistant will collect all information and annotations recorded on the patient's medical file during the procedure.
In the treatment group (operating room equipped with the CADe), the Medtronic-GI genius system can be used for real-time support by the endoscopists to detect polyps of all sizes. Use of CADe is left to the discretion of the treating physician performing the colonoscopy. If used, CADe will provide real-time feedback throughout each colonoscopy procedure and will alert the endoscopists of the presence of a polyp in the endoscopy field by displaying a bounding box on the same screen.
In the control group (colonoscopy performed in room without CADe system), the participating endoscopists will detect as per standard of care.
All colonoscopies (in the intervention and control groups) including polypectomy procedures will be performed at the discretion of the treating physician and per standard of care.
All polyps will be resected as per standard of care and sent to the pathology labs of the participating institutions to be evaluated for histology by board-certified pathologists. The histopathology outcomes will be collected and stored in the CRF forms to be used as a reference later.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- pragmatic double-blinded, randomized, multi-endoscopist, multicenter
| Arm | Type | Receives |
|---|---|---|
| Operating room equipped with the CADe (Medtronic-GI genius for real-time detection) | Experimental | Device: Medtronic-GI genius (CADe system for detecting colorectal polyps)The Medtronic-GI genius (CADe) system can be used to detect polyps of all sizes. Use of CADe is left to the discretion of the treating physician performing the colonoscopy. If used CADe will provide real-time feedback throughout each colonoscopy procedure and will alert the endoscopists of the presence of a polyp in the endoscopy field by displaying a bounding box on the same screen. |
| Colonoscopy performed in room without CADe system | No intervention | –In the control group (standard colonoscopy), the participating endoscopists will detect and classify colorectal lesions without using any AI modules. |
Who may qualify
- Ages
- 45 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- indication of undergoing a screening, surveillance, or diagnostic colonoscopy
- Age 45-89 years
Key exclusion criteria (2 listed)
- Patients undergoing emergency colonoscopy
- Patients with a known familial polyposis syndrome or a known inflammatory bowel disease
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 |
|---|---|---|
| Medtronic-GI genius (CADe system for detecting colorectal polyps)Medtronic-GI genius: AI will provide real-time feedback throughout each colonoscopy procedure and alert endoscopists to the presence of a polyp in the endoscopy field by displaying a bounding box on the same screen. | Device | Operating room equipped with the CADe (Medtronic-GI genius for real-time detection) |
Primary outcome
ADR
Time frame: 30 days
The adenoma detection rate (ADR) is defined as the proportion of colonoscopies with at least 1 histopathologically proven adenoma or carcinoma detected.
7 secondary outcomes
Mean number of adenomas per colonoscopy (APC)
Time frame: 30 days
Sessile serrated lesions (SSL) detection rate
Time frame: 30 days
Sessile serrated lesion per Colonoscopy (SSLPC)
Time frame: 30 days
Advanced lesion detection rate (ALDR)
Time frame: 30 days
Proximal ADR
Time frame: 30 days
Proportion neoplastic and non-neoplastic polyps
Time frame: 30 days
CADe utilization rate
Time frame: Through study completion, an average of 3 years
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 21 Sep 2026.
- 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.
Centre Hospitalier Universitaire de Montréal
Montreal, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic-GI genius (CADe system for detecting colorectal polyps) in people with Artificial Intelligence, 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADR (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2026.