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

Jubaan Ltd.426 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

426

Conditions

Colorectal Neoplasms Gastrointestinal Microbiome

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

NYU Langone Health

New York, New York, United States

Westside GI

New York, New York, United States

NewYork-Presbyterian / Columbia University Irving Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

Primary Safety Endpoint - Number of device related adverse events and serious adverse events

Time frame: 1 day

Primary Efficacy Endpoint - Gixam's diagnostic accuracy

Gixam's diagnostic accuracy (sensitivity and specificity) of adenomatous colorectal polyps. The Gixam's predictive value will be compared to the patient's colonoscopy + pathology (if any specimens are collected) findings as ground truth on a binary basis (YES/NO for adenomatous and sessile serrated polyps).

Time frame: 14 days (till pathology report is received)