Gixam device to spot advanced or non-advanced colon cancer in people 45–84 who had a negative FIT

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults at average risk for colorectal cancer scheduled for screening colonoscopy will undergo the Gixam test and a home FIT, then have a standard screening colonoscopy. The study compares Gixam results with colonoscopy findings to see if Gixam can identify hidden lesions after a negative FIT and to assess safety. Participants must meet age and risk criteria and will provide informed consent. The trial is conducted at sites in Alabama and California and is sponsored by Jubaan Ltd.

Why it matters

Who can join: the full rules

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 (FOBT) result within the preceding eleven (11) months.
4. Positive Cologuard, Sheild, ColoSense or Epi proColon test within the preceding three (3) years.
5. History of colorectal cancer.
6. Family history of colorectal cancer, defined as having one or more first- degree relatives (parent, sibling, or child) with CRC at any age.
7. Participant 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 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.
8. Participant has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn's disease.
9. Participants with a disability to extend their tongue.
10. Participants with tongue tremor.
11. Participants with tongue piercing.
12. Participants that had a dental visit in the 7 days prior to the Gixam test.
13. Participants that have taken antibiotics or anti-fungal medications in the 14 days prior to the Gixam test.
14. Participants that have taken probiotics in the 14 days prior to the Gixam test.
15. Participant is pregnant.
16. Participant has any condition that in the opinion of the Investigator should preclude participation in the study.

Where it's running

• Digestive Health Specialist
  Dothan, Alabama, United States Recruiting
• East View Medical Research, LLC
  Mobile, Alabama, United States Recruiting
• Gastro Care Institute
  Lancaster, California, United States Recruiting
• Orlando Gastroenterology, PA
  Orlando, Florida, United States Recruiting
• Westchester Putnam Gastro
  Carmel, New York, United States Recruiting
• NYU Langone Health
  New York, New York, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.