Evaluation of Gixam's Efficacy Predicting the Presence of Advanced and Non-advanced Colorectal Neoplasia in a FIT Negative Population
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.
Eligibility
- Age range
- 45–84 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Participants aged ≥45 - ≤84 years. 2. Able to provide a signed informed consent. 3. Considered by a physician or healthcare provider as being of 'average risk' for CRC. 4. Scheduled for a screening colonoscopy at investigation site. Exclusion Criteria: 1. Undergoing colonoscopy for investigation of symptoms. 2. Has undergone colonoscopy within preceding nine (9) years except for a failed colonoscopy due to poor bowel preparation. Failed colonoscopy must have been within the past year and without therapeutic intervention. 3. Positive FIT or Fecal Occult Blood Test (FOB…