AI-Assisted Optical Diagnosis (CADx) for Diminutive Colorectal Polyps

NCT07738484 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: MP-02-2027-13785
• Study Type: observational
• Target: 840
• Locations: 0 countries
• Sites: N/A

Brief 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, 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.

Conditions

Colorectal Polyps; Colorectal Adenoma; Diminutive Colorectal Polyp

Keywords

CADx; Computer-Aided Diagnosis; Optical Diagnosis; Colonoscopy; Diminutive Colorectal Polyps; Colorectal Adenoma; GI Genius; Artificial Intelligence; Diagnostic Accuracy; Real-time Characterization; STARD; Histopathology

Outcome Measures

Primary Outcomes (2)

• 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%)

  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%)

  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)

  Within 14 to 45 days after polypectomy (colorectal polyp resection during the index colonoscopy), once histopathology results are available

• Surveillance interval agreement

  Outcome assessed throughout the 24-month recruitment period, with total study duration of 36 months

• Sensitivity and specificity, rectosigmoid subset

  Outcome assessed throughout the 24-month recruitment period, with total study duration of 36 months

• CADx-assisted vs. CADx-unassisted diagnostic performance

  Outcome assessed throughout the 24-month recruitment period, with total study duration of 36 months

• High-confidence prediction rate

  Outcome assessed throughout the 24-month recruitment period, with total study duration of 36 months

Other Outcomes (2)

• Health economic outcome

  Outcomes assessed throughout the 24-month recruitment period, with total study duration of 36 months

• Subgroup diagnostic performance

  Outcome assessed throughout the 24-month recruitment period, with total study duration of 36 months

Study Arms (1)

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.

Device: GI Genius CADx module (Medtronic)

Interventions

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.

Diminutive Colorectal Polyps - CADx-Assisted Optical Diagnosis

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Signed informed consent, obtained before the colonoscopy and before sedation
• Age 45-80 years
• Indication for elective colonoscopy (screening, surveillance, or diagnostic)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Related Publications (12)

• 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.

  PMID: 32598963 BACKGROUND

• Biffi 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.

  PMID: 35773468 BACKGROUND

• Byrne 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.

  PMID: 29066576 BACKGROUND

• Mori 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.

  PMID: 30105375 BACKGROUND

• Husereau 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.

  PMID: 35017145 BACKGROUND

• Hassan 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.

  PMID: 20621680 BACKGROUND

• 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.

  PMID: 38331204 BACKGROUND

• Bossuyt 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.

  PMID: 26511519 BACKGROUND

• Dekker 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.

  PMID: 32882737 BACKGROUND

• Houwen 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.

  PMID: 34872120 BACKGROUND

• ASGE 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.

  PMID: 25597420 BACKGROUND

• Rex 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.

  PMID: 21353837 BACKGROUND

Related Links

• Related Info

Central Study Contacts

Daniel von Renteln, Doctor of Medicine (MD), Gastr

CONTACT

514-890-8000; daniel.von.renteln.med@ssss.gouv.qc.ca

Samira Hanin, Research Coordinator

CONTACT

514-890-8000; samira.hanin.chum@ssss.gouv.qc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 31, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share