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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Neoplasms; Gastrointestinal Microbiome
• Intervention / Treatment: Device: Gixam

• Study Type: Interventional
• Enrollment (Actual): 426
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health
    • New York, New York, United States, 10019
      • Westside GI
    • New York, New York, United States, 10032
      • NewYork-Presbyterian / Columbia University Irving Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gixam followed by standard of care colonoscopy; This is a single-arm study. All participants will undergo the Gixam test following a standard of care colonoscopy	Device: Gixam; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Jubaan Ltd.
• Investigators: Study Director: Daniella Bleistein, Jubaan Ltd.

Publications and helpful links

Helpful Links

• Jubaan's website

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 10, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Artificial Intelligence
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplasms, Glandular and Epithelial; Colonic Diseases; Adenoma; Colorectal Neoplasms; Adenomatous Polyps
• Other Study ID Numbers: CL-1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No