NCT06305364Completed
Predicting Adenomatous Polyps in the Colon Using Images of a Human Tongue
Predicting Adenomatous Polyps in the Colon, Using Images of a Human Tongue
Source: ClinicalTrials.gov · Last updated 20 Feb 2025
Brief summary (registry, in English)
This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the accuracy of the Gixam™ 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 Gixam™ System and a prediction score will be generated by the Gixam™ AI model. Subjects will thereafter proceed to their SOC colonoscopy, and the Gixam™ score will be compare with colonoscopy findings to evaluate its performance.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 426 (actual)
- First submitted
- 5 Mar 2024
- Start date
- 1 Aug 2023
- Primary completion date
- 31 Dec 2024
- Lead sponsor
- Jubaan Ltd.
- Diseases
- Colorectal cancer
- NCT number
- NCT06305364
What you commit to
- Study type: Interventional
- Participants enrolled: 426
- From 1 Aug 2023 to the primary completion date, 31 Dec 2024
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or previous Inflammatory Bowel Disease (IBD - Crohn's, Ulcerative Colitis) of significant duration
Other illness
- Lynch or Familial Adenomatous Polyposis (FAP) inherited syndromes
Other
- Subject who is not a suitable candidate for a colonoscopy
- Patients with a disability to extend their tongue.
- Patients with tongue piercings.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Westside GI Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| NewYork-Presbyterian / Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| NYU Langone Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.