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Evaluation of Gixam's Performance in a FIT Negative Population

NCT06612281 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2024-11-14

No results posted yet for this study

Summary

In the United States, colorectal cancer ranks second to lung cancer as a cause of cancer death and is the third most commonly occurring cancer in both men and women. Colorectal cancer in most cases develops slowly over a period of years, starting with the growth of precancerous polyps on the colon or rectum wall. The slow development of colorectal cancer makes it possible to detect and prevent it entirely by the removal of the precancerous polyps with colonoscopy. To date, there is no screening test, other than colonoscopy, able to detect the precancerous polyps. Gixam is a camera that takes multiple pictures of your tongue and uses artificial intelligence software to predict the presence of precancerous polyps within your colon or rectum that may eventually become cancerous.

The device creates the prediction by comparing the images taken of your tongue with many other images of tongues from healthy patients and patients with a history of precancerous polyps. Patients who have been predicted by Gixam to have precancerous polyps may be more likely to complete colonoscopy at the interval recommended by their physician, potentially reducing the likelihood of developing colorectal cancer.

The purpose of this research study is to test the accuracy of the Gixam device in persons that have received a negative outcome on a Fecal Immunochemical Test (FIT). This study will compare this prediction to the actual findings of your scheduled standard care colonoscopy and allow researchers to evaluate and improve the Gixam system.

Conditions

  • Colorectal Adenoma
  • Colorectal Cancer (CRC)
  • Colorectal Cancer (CRC) Screening

Interventions

DEVICE

colorectal cancer (CRC) screening

Gixam test

DIAGNOSTIC_TEST

colorectal cancer screening

Fecal Immunochemistry Test (FIT)

PROCEDURE

Colonoscopy after bowel cleansing

Standard of care optical colonoscopy for colorectal cancer screening

Sponsors & Collaborators

  • Jubaan Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2025-03-30
Completion
2025-04-30
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 NCT06612281 on ClinicalTrials.gov