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

NCT ID: NCT06305364

Condition: Colorectal Neoplasms
Gastrointestinal Microbiome

Conditions: Official terms:
Colorectal Neoplasms
Adenomatous Polyps

Conditions: Keywords:
Artificial Intelligence

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Screening

Masking: None (Open Label)

Masking description: Gastroenterologist performing standard of care colonoscopy post Gixam test will be blinded to the Gixam prediction score.

Intervention:

Intervention type: Device
Intervention name: Gixam
Description: 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.
Arm group label: Gixam followed by standard of care colonoscopy

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: NYU Langone Health

Address:
City: New York
Zip: 10016
Country: United States

Status: Recruiting

Contact:
Last name: Peter Emanuel

Phone: 212-263-6340
Email: peter.emanuel@nyulangone.org

Facility:
Name: Westside GI

Address:
City: New York
Zip: 10019
Country: United States

Status: Recruiting

Contact:
Last name: Theodore Bortz

Facility:
Name: NewYork-Presbyterian / Columbia University Irving Medical Center

Address:
City: New York
Zip: 10032
Country: United States

Status: Recruiting

Contact:
Last name: Elissa Lynch

Contact backup:
Last name: Daniel Freedberg, MD

Start date: August 1, 2023

Completion date: December 1, 2024

Lead sponsor:
Agency: Jubaan Ltd.
Agency class: Industry

Source: Jubaan Ltd.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06305364
https://jubaan.com/

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