Evaluation of Gixam's Efficacy Predicting the Presence of Advanced and Non-advanced Colorectal Neoplasia in a FIT Negative Population
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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
Primary outcome measure(s)
- Primary Safety Endpoint — From enrollment to the end of study at 30 days after
Number of device-related adverse events and serious adverse events. - Primary Efficacy Endpoints — Through study completion, an average of 30 days
Sensitivity and specificity of Gixam in participants with a negative FIT result.
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| Digestive Health Specialist | Dothan | Alabama | Recruiting |
| East View Medical Research, LLC | Mobile | Alabama | Recruiting |
| Gastro Care Institute | Lancaster | California | Recruiting |
| Orlando Gastroenterology, PA | Orlando | Florida | Recruiting |
| Comprehensive Gastrointestinal Health, LLC | Northbrook | Illinois | Active Not Recruiting |
| Westchester Putnam Gastro | Carmel | New York | Recruiting |
| NYU Langone Health | New York | New York | Recruiting |
| Great Lakes Gastroenterology Research, LLC | Mentor | Ohio | Recruiting |
| Blue Ridge Medical Research | Lynchburg | Virginia | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07623902 on ClinicalTrials.gov ↗ ← All trials in the USA