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

NCT06305364 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 426

Last updated 2025-02-20

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Jubaan Ltd.

    lead INDUSTRY

Principal Investigators

  • Daniella Bleistein · Jubaan Ltd.

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06305364 on ClinicalTrials.gov