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Evaluation of Gixam's Efficacy Predicting the Presence of Advanced and Non-advanced Colorectal Neoplasia in a FIT Negative Population
Sponsor: Jubaan Ltd.
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
Conditions
Interventions
Gixam System
All participant will undergo the Gixam test per device instructions for use
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.
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