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

Not Applicable

Completed

• Conditions: Gastrointestinal Microbiome; Colorectal Neoplasms
• Interventions: Device: Gixam

• Registration Number: NCT06305364
• Lead Sponsor: Jubaan Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-01
• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-03-10
• Study First Posted: 2024-03-12
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 426

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint - Number of device related adverse events and serious adverse events	1 day
Primary Efficacy Endpoint - Gixam's diagnostic accuracy	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).

Trial Locations

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