NCT06305364

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 426 (actual)
• Sponsor: Jubaan Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-03-12
• Last updated: 2025-02-20

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study