NCT05080088CompletedNot Applicable
A Pilot Study: Retrospective Evaluation of 3 Colonic Adenoma Detection Strategies During a Colonoscopy: Endoscopy Cap Associated With the Artificial Intelligence GI GENIUS ™ System, the Artificial Intelligence GI GENIUS ™ Alone and Colonoscopy Alone
Centre Hospitalier Universitaire de Nīmes1 site in 1 country90 target enrollmentStarted: April 6, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Colonic Adenomas Detection Rate according to the use of the Combine Techniques GENIUS software - Cap or Only GENIUS software
Study Overview
Brief Summary
Retrospective study, single blind (patient), allowing a posteriori clinical data collection of 90 patients during their passage to the ambulatory endoscopy circuit, to consider 3 groups and thus to deduce a colonic adenoma detection rate for each arm :
- Colonoscopy Only Group
- Artificial intelligence only group (IA GI GENIUS ™ alone)
- Endoscopic Cap and Artificial Intelligence Group (endoscopy cap associated with the GI GENIUS ™ IA System)
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Colonic Adenomas Detection Rate according to the use of the Combine Techniques GENIUS software - Cap or Only GENIUS software
Time Frame: 4 months
number of colonoscopies with the discovery of at least 1 colonic adenoma out of the total number of colonoscopies according to the use of colonoscopy alone / artificial intelligence alone / artificial intelligence combined with the endoscopic cap.
Secondary Outcomes
- Withdrawal time(4 months)
- Adenomas Rate according to their size(4 months)
- Adenomas Rate according to their morphology(4 months)
- Adenomas Rate according to their histology(4 months)
- Caecal Intubation Rate(4 months)
- Adverse effects(4 months)
Investigators
Clément Delliot
medical student
Centre Hospitalier Universitaire de Nīmes
Study Sites (1)
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