Predicting Adenomatous Polyps in the Colon Using Images of a Human Tongue (NCT06305364) | Clinical Trial Compass
CompletedNot Applicable
Predicting Adenomatous Polyps in the Colon Using Images of a Human Tongue
United States426 participantsStarted 2023-08-01
Plain-language summary
This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the accuracy of the Gixamâ„¢ System in identifying subjects with colorectal adenomas compared to optical colonoscopy. Subjects arriving for a standard of care colonoscopy at the investigation site will be offered to participate in the study. Following an informed consent process, images of the subjects' tongue will be obtained with the Gixamâ„¢ System and a prediction score will be generated by the Gixamâ„¢ AI model. Subjects will thereafter proceed to their SOC colonoscopy, and the Gixamâ„¢ score will be compare with colonoscopy findings to evaluate its performance.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Males or females
✓. Age: 18-75 years, inclusive
✓. Scheduled for colonoscopy procedure at investigation site subject to one of the below criteria:
✓. Screening - defined as first colonoscopy or consecutive colonoscopy without previous findings, previous colonoscopy performed at least 10 years ago (- 1 year);
✓. Patient with finding of colorectal adenoma or sessile serrated polyp in previous colonoscopy (must be documented in patient's medical history).
✓. Able to comprehend and provide informed consent.
Exclusion criteria
✕. Subject who is not a suitable candidate for a colonoscopy
✕. Lynch or Familial Adenomatous Polyposis (FAP) inherited syndromes
✕. Current or previous Inflammatory Bowel Disease (IBD - Crohn's, Ulcerative Colitis) of significant duration
What they're measuring
1
Primary Safety Endpoint - Number of device related adverse events and serious adverse events