Evaluation of Gixam's Efficacy Predicting the Presence of Advanced and Non-advanced Colorectal Neoplasia in a FIT Negative Population
Start Date
5/18/2026
Completion Date
12/31/2026
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.
Eligibility Criteria
Age Range: 45 years to 84 years
Interventions
Gixam System
FIT
Standard of care screening colonoscopy
Conditions
Locations
East View Medical Research, LLC
Mobile, Alabama 36606
United States
Gastro Care Institute
Lancaster, California 93534
United States
Orlando Gastroenterology, PA
Orlando, Florida 32835
United States
Comprehensive Gastrointestinal Health, LLC
Northbrook, Illinois 60062
United States
Westchester Putnam Gastro
Carmel, New York 10549
United States
NYU Langone Health
New York, New York 10016
United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio 44060
United States
Blue Ridge Medical Research
Lynchburg, Virginia 24502
United States