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.
Participants aged ≥45 - ≤84 years.
Able to provide a signed informed consent.
Considered by a physician or healthcare provider as being of 'average risk' for CRC.
Scheduled for a screening colonoscopy at investigation site.
Undergoing colonoscopy for investigation of symptoms.
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.
Positive FIT or Fecal Occult Blood Test (FOBT) result within the preceding eleven (11) months.
Positive Cologuard, Sheild, ColoSense or Epi proColon test within the preceding three (3) years.
Single group
Gixam System
DeviceAll participant will undergo the Gixam test per device instructions for use
FIT
Diagnostic testFIT 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
Procedure/SurgeryAll participants will undergo a standard of care screening colonoscopy which serves as the gold truth in this study
Primary Safety Endpoint
Number of device-related adverse events and serious adverse events.
Primary Efficacy Endpoints
Sensitivity and specificity of Gixam in participants with a negative FIT result.
Confirmatory Secondary Efficacy Endpoints
Standalone sensitivity and specificity of Gixam in general average risk population.
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