2026-09-22
notable
Primary completion pushed: 2026-08-01 → 2027-01-01
2025-02-28
minor
Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Study Design, Outcome Measures, Eligibility, Contacts/Locations v7
Primary completion date2024-08-01→2026-08-01
Completion date2025-01-01→2027-01-01
Enrollment target798→1596
Eligibility criteria-4 characters
[...] xclusion Criteria:
Patients undergoing emergency colonoscopy and patients
Patients with a known familial polyposis syndrome or a known inflammatory bowel disease
Secondary endpoints10 to 7 entries
Non-detection rate by the GI genius system
Adenomas per positive index colonoscopy (APPC)
Agreement between the surveillance intervals
Primary endpoints1 entry, revised
Detection rate of colorectal adenomas when using the GI genius platformADR
Study description+59 characters
[...] ible 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 CADCADe system.
Control arm: patients will undergo colonoscopy in a [...] f the treating physician performing the colonoscopy.
If used, CADe will provide real-time feedback throughout each colono [...] sician and per standard of care.
All polyps will be resected as per standard of care and sent to the pathology labs of the participating institu [...]
Study sitescontacts updated at 1 of 1 site
Study title+19 characters
Artificial Intelligence (AI) Assisted Real-time Adenoma Detection and Classification During Colonoscopies
2023-12-14
notable
Not Yet Recruiting→Recruiting Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Contacts/Locations v6
Trial statusNot Yet Recruiting→Recruiting
Enrollment target744→798
InterventionsDetection and classification of polyps by Artificial Intelligence Medtronic-GI genius (Diagnostic Test)→Medtronic-GI genius (CADe system for detecting colorectal polyps) (Device)
Study description-87 characters
This trial will be conducted in fivefour centers across Canada.
All patients who meet the in/exclusi [...] copy in a room not equipped with the GI genius CADe system.
AllocationThe will be concealed and study participation not know to the endoscopistendoscopists performing the procedurecolonoscopies 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 studydesign willaims to mitigate operator biases that may be apartly pragmaticresponsible double-bli [...] [...]
Study sitesdetails revised at 1 of 1 site
2023-06-28
minor
Study Status, Study Description, Outcome Measures, Eligibility v5
Start date2023-06-01→2023-08-01
Eligibility criteria-477 characters
Inclusion Criteria:
indication of undergoing a screening, surveillance, or diagnostic colonoscopy
Age 45-8089 years Signed informed consent Patients at a high risk of having neoplastic colorectal polyps include those patients referred to a colonoscopy for a positive FIT, first-degree family history of CRC, personal history of CRC, and history of having had an or adenomatous and serrated lesions in a previous col [...]
Exclusion Criteria:
Patients undergoing emergency colonoscopy and patients with a known familial polyposis syndrome or a known inflammatory bowel disease, active colitis, coagulopathy [...]
Secondary endpoints6 to 10 entries
Sessile serrated lesion per Colonoscopy (SSLPC)
Advanced lesion detection rate (ALDR)
Proportion neoplastic and non-neoplastic polyps
CADe utilization rate
Study description-10 characters
This trial will be conducted in five centers (Table 1) across Canada.
All patients who meet the in/exclusion criter [...]
2023-05-09
minor
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions v4
Start date2023-04-01→2023-06-01
Study description-1,232 characters
This prospective randomized controlled trial will be conducted in five centers (Table 1) across Ca [...] ied per center in two arms:
Intervention arm: patients will be assigned to undergo colonoscopy usingin a room equipped with the GI genius CAD system.
Control arm: patients will undergo colonoscopy in a standardroom colonoscopynot withoutequipped usingwith the GI genius AICADe system.
Allocation will be concealed, and thestudy participatingparticipation endoscopistsnot willknow be informed byto the treatmentendoscopist group just beforeperforming the procedure in the endoscopy unit.
This study will [...] [...]
Study title-19 characters
Artificial Intelligence (AI) Assisted Real-time Adenoma Detection and Classification During Colonoscopies
Show 3 earlier versions
2023-02-07
minor
Study Status v3
Start date2023-01-01→2023-04-01
2022-12-09
minor
Study Status, Sponsor/Collaborators, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v2
Primary completion date2022-10-01→2024-08-01
Completion date2023-04-01→2025-01-01
Start date2022-04-01→2023-01-01
Enrollment target625→744
Study arms1→2
Eligibility criteria+168 characters
[...] agnostic colonoscopy Age 45-80 years Signed informed consent Patients at a high risk of having neoplastic colorectal polyps include those patients referred to a colonoscopy for a positive FIT, first-degree family history of CRC, personal history of CRC, and history of having had an or adenomatous and serrated lesions in a previous colonoscopy.
Exclusion Criteria:
Knownpatients with known inflammatory bowel disease (IBD) Poor general health, definedactive ascolitis, an American Society of Anesthesiologists (ASA) physical status class >3 Coagulopathycoagulopathy defined as an elevated INR (Inter [...] [...]
Secondary endpoints2 to 6 entries
nonNon-detection rate by the GI genius system
agreementProximal ADR
Sessile serrated lesions (SSL) detection rate
Mean number of adenomas per colonoscopy (APC)
Adenomas per positive index colonoscopy (APPC)
Agreement between the surveillance intervals
Primary endpoints1 entry, revised
detectionDetection rate of colorectal adenomas when using the GI genius platform
Study description+3,825 characters
This prospective randomized controlled trial will be conducted in five centers (Table 1) 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 [...]
Collaborators+95 characters
McGill University
University of British Columbia
Université de Sherbrooke
University of Alberta
2022-02-19
minor
Study Identification, Study Status, Arms and Interventions, Eligibility v1
InterventionsDetection and classificationof polyps by Artificial Intelligence Medtronic-GI genius (Diagnostic Test)→Detection and classification of polyps by Artificial Intelligence Medtronic-GI genius (Diagnostic Test)
Eligibility criteria+33 characters
[...] ical status class >3 Coagulopathy defined as an elevated INR (International Normalized Ratio) ≥2.5 or platelet count <50,000/mm3 Familial polyposis syndr [...]
Study title+6 characters
ArtificalArtificial Intelligence (AI) Assisted Real-time Adenoma Detection and Classification During Colonoscopies
2022-02-08
minor
Original filing