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

NCT06305364 | Completed DMC FDA Device

• 1 other identifier: CL-1001
• Study Type: interventional
• Target: 426
• Locations: 1 country
• Sites: 3

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.

Conditions

Colorectal Neoplasms; Gastrointestinal Microbiome

Keywords

Artificial Intelligence

Outcome Measures

Primary Outcomes (2)

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

  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).

  14 days (till pathology report is received)

Study Arms (1)

Gixam followed by standard of care colonoscopy

EXPERIMENTAL

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

Device: Gixam

Interventions

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.

Gixam followed by standard of care colonoscopy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jubaan Ltd.: lead

Study Sites (3)

NYU Langone Health

New York, New York, 10016, United States

Location

Westside GI

New York, New York, 10019, United States

Location

NewYork-Presbyterian / Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Links

• Jubaan's website

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Daniella Bleistein

  Jubaan Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Gastroenterologist performing standard of care colonoscopy post Gixam test will be blinded to the Gixam prediction score.
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: August 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)