RecruitingPhase 2NCT06612281

Evaluation of Gixam's Performance in a FIT Negative Population


Sponsor

Jubaan Ltd.

Enrollment

400 participants

Start Date

Nov 1, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 45 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates a new colon cancer screening tool called Gixam in people who recently had a negative fecal immunochemical test (FIT) — a common stool-based screening test. Gixam may be able to detect colorectal polyps or cancer that FIT missed. **You may be eligible if...** - You are between 45 and 85 years old - You are scheduled for a routine screening colonoscopy - You are able to provide written informed consent **You may NOT be eligible if...** - You are getting a colonoscopy for symptoms (not routine screening) - You have had a colonoscopy in the past 3 years - You have a prior history of colorectal cancer or inflammatory bowel disease - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEcolorectal cancer (CRC) screening

Gixam test

DIAGNOSTIC_TESTcolorectal cancer screening

Fecal Immunochemistry Test (FIT)

PROCEDUREColonoscopy after bowel cleansing

Standard of care optical colonoscopy for colorectal cancer screening


Locations(1)

The Oregon Clinic Gastroenterology-East

Portland, Oregon, United States

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NCT06612281


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