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RECRUITING
NCT07623902
NA

Evaluation of Gixam's Efficacy Predicting the Presence of Advanced and Non-advanced Colorectal Neoplasia in a FIT Negative Population

Sponsor: Jubaan Ltd.

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if the Gixam device effectively identifies persons with pre-cancer or cancer in the colon and rectum in adults aged 45-84 that are of average risk to develop colorectal cancer and have received a negative result on a Fecal Immunochemical Test (FIT). The main questions it aims to answer are: 1. Is the Gixam Device effective in identifying persons with pre-cancer or cancer in the colon and rectum that have received a negative FIT result? 2. Is the use of the Gixam device safe? Gixam test result will be compared to the findings of a standard of care screening colonoscopy. Study participants will: 1. Undergo the Gixam test 2. Take a FIT at home and ship to a laboratory. 3. Undergo a standard of care screening colonoscopy.

Key Details

Gender

All

Age Range

45 Years - 84 Years

Study Type

INTERVENTIONAL

Enrollment

1436

Start Date

2026-05-18

Completion Date

2026-12-31

Last Updated

2026-06-03

Healthy Volunteers

No

Interventions

DEVICE

Gixam System

All participant will undergo the Gixam test per device instructions for use

DIAGNOSTIC_TEST

FIT

FIT kit will be handed out to the study participant, who will later sample stool at home and mail the specimen to a reference laboratory for analysis.

PROCEDURE

Standard of care screening colonoscopy

All participants will undergo a standard of care screening colonoscopy which serves as the gold truth in this study

Locations (5)

Orlando Gastroenterology, PA

Orlando, Florida, United States

Comprehensive Gastrointestinal Health, LLC

Northbrook, Illinois, United States

Westchester Putnam Gastro

Carmel, New York, United States

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, United States

Blue Ridge Medical Research

Lynchburg, Virginia, United States