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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

426 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Colorectal Neoplasms Gastrointestinal Microbiome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

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

Study Groups

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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

Group Type EXPERIMENTAL

Gixam

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes