Evaluation of Gixam's Performance in a FIT Negative Population

Part of paid clinical trials in Portland, Oregon.

Sponsor
Jubaan Ltd.
Study ID
NCT06612281
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
45 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • colorectal cancer (CRC) screening — DEVICE
    Gixam test
  • colorectal cancer screening — DIAGNOSTIC_TEST
    Fecal Immunochemistry Test (FIT)
  • Colonoscopy after bowel cleansing — PROCEDURE
    Standard of care optical colonoscopy for colorectal cancer screening

Study Details

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.

Key Dates

Start date
Nov 1, 2024
Status verified
Nov 2024
Primary completion
Mar 30, 2025
Completion
Apr 30, 2025

Study Design

Enrollment
400 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

  • Experimental: Single arm
    All participants will undergo the same study procedures: FIT, Gixam, and colonoscopy

Primary Outcome Measure

Safety - number of device related adverse events and serious adverse events [ Time Frame: Through study completion, up to 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Oregon Clinic Gastroenterology-EastPortlandOregon97220
Diane Snelson
[email protected]
503-963-2782

Find similar trials in Portland, OR

By research site
The Oregon Clinic Gastroenterology-East· Portland, OR

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