Predicting Adenomatous Polyps in the Colon Using Images of a Human Tongue

Jubaan

Status: Completed

Conditions: Colorectal Neoplasms; Gastrointestinal Microbiome

Treatments: Device: Gixam

Study type: Interventional

Funder types: Industry

Identifiers

NCT06305364

CL-1001

Details and patient eligibility

About

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.

Enrollment: 426 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Males or females

2. Age: 18-75 years, inclusive

3. Scheduled for colonoscopy procedure at investigation site subject to one of the below criteria:

   1. Screening - defined as first colonoscopy or consecutive colonoscopy without previous findings, previous colonoscopy performed at least 10 years ago (- 1 year);
   2. Patient with finding of colorectal adenoma or sessile serrated polyp in previous colonoscopy (must be documented in patient's medical history).

4. Able to comprehend and provide informed consent.

Exclusion criteria

1. Subject who is not a suitable candidate for a colonoscopy
2. Lynch or Familial Adenomatous Polyposis (FAP) inherited syndromes
3. Current or previous Inflammatory Bowel Disease (IBD - Crohn's, Ulcerative Colitis) of significant duration
4. Patients with a disability to extend their tongue.
5. Patients with tongue piercings.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

426 participants in 1 patient group

Gixam followed by standard of care colonoscopy

Experimental group

Description:

This is a single-arm study. All participants will undergo the Gixam test following a standard of care colonoscopy

Treatment:

Device: Gixam