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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Microbiome Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health, New York, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
Patients with a disability to extend their tongue.
Patients with tongue piercings.

Treatment and study plan

Gixam

Device

Participants will be required to extend their tongue in the Gixam device. Six images will be obtained and analyzed by the artificial intelligence (AI) model generating a prediction score for the presence of colorectal adenoma.

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

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

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).

Sponsors and collaborators

Lead sponsor

Jubaan Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Mar 12, 2024
Registry last updated: Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed