Evaluation of Gixam's Efficacy Predicting Pre-cancerous Colorectal Polyps and Colorectal Cancer

Evaluation of Gixam's Efficacy Predicting Pre-cancerous Colorectal Polyps and Colorectal Cancer

This is a prospective, single arm, multi-center clinical investigation aim to demonstrate the efficacy of Gixam in predicting the presence of premalignant colorectal polyps and colorectal cancer (CRC) in a fecal immunochemical test (FIT) positive population.

1. Average risk persons eligible for CRC screening that have received a positive FIT outcome in the past 6 months and are scheduled for a screening colonoscopy at one of the participating centers will be offered to participate in the study.

2. Following the informed consent process, subjects will undergo the Gixam test.

   1. A subset of 50 subjects will participate in the repeatability assessment. They will undergo three (3) repetitive Gixam tests one after the other, by the same operator.
   2. Both the subject and the endoscopist will be blinded to the Gixam outcome

3. All subjects will thereafter undergo a standard of care HD-WL colonoscopy procedure.

4. All resected and retrieved lesions will be sent separately for histopathological evaluation.

Inclusion Criteria:

1. Subjects aged ≥50 - ≤80 years.
2. Able to provide a signed informed consent.
3. Underwent FIT screening within the past 6 months with a positive result.
4. Scheduled for a FIT positive screening colonoscopy at investigational site.

Exclusion Criteria:

1. Has undergone colonoscopy within the past nine (9) years, except for a failed colonoscopy due to poor bowel preparation, which must have been performed within the past year without therapeutic intervention.

2. Personal history of CRC.

3. Family history of CRC, defined as having one or more first-degree relatives (parent, sibling, or child) with CRC at any age.

4. Subject has a diagnosis or medical / family history of any of the following conditions, including:

   • Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome),
   • Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome"),
   • Other hereditary cancer syndromes including but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis, or Familial Hyperplastic Polyposis.

5. Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis, and/or Crohn's disease, and/or IBD-undefined.

6. Subjects with the disability to extend their tongue.

7. Subjects with tongue piercing.

8. Dental visit in the 7 days prior to the Gixam test.

9. Intake of pro-biotics over the past 3 months pre-Gixam test.

10. Subject has any condition that in the opinion of the Investigator should preclude participation in the study.