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

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06305364
• Other study ID #: CL-1001
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2024
• Source: Jubaan Ltd.
• Contact: Daniella Bleistein
• Phone: +9724643-2991
• Email: daniella[@]jubaan.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenomatous Polyps
• Colorectal Neoplasms
• Gastrointestinal Microbiome

Intervention

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.

Locations

Country	Name	City	State
United States	NewYork-Presbyterian / Columbia University Irving Medical Center	New York	New York
United States	Westside GI	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Jubaan Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety Endpoint - Number of device related adverse events and serious adverse events		1 day
Primary	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)

External Links

•   Jubaan's website