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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
1,436
All participant will undergo the Gixam test per device instructions for use
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.
All participants will undergo a standard of care screening colonoscopy which serves as the gold truth in this study
East View Medical Research, LLC
Mobile, Alabama, United States
RECRUITINGGastro Care Institute
Lancaster, California, United States
RECRUITINGOrlando Gastroenterology, PA
Orlando, Florida, United States
RECRUITINGComprehensive Gastrointestinal Health, LLC
Northbrook, Illinois, United States
ACTIVE_NOT_RECRUITINGWestchester Putnam Gastro
Carmel, New York, United States
RECRUITINGNYU Langone Health
New York, New York, United States
RECRUITINGGreat Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States
RECRUITINGBlue Ridge Medical Research
Lynchburg, Virginia, United States
RECRUITINGPrimary Safety Endpoint
Number of device-related adverse events and serious adverse events.
Time frame: From enrollment to the end of study at 30 days after
Primary Efficacy Endpoints
Sensitivity and specificity of Gixam in participants with a negative FIT result.
Time frame: Through study completion, an average of 30 days
Confirmatory Secondary Efficacy Endpoints
Standalone sensitivity and specificity of Gixam in general average risk population.
Time frame: Through study completion, an average of 30 days
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