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Evaluation of Gixam's Efficacy Predicting the Presence of Advanced and Non-advanced Colorectal Neoplasia in a FIT Negative Population

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years to 84 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether the Gixam device can safely find cancer or growths that may turn into cancer in the colon and rectum. It is for adults ages 45–84 at average risk for this cancer who have a negative FIT, a stool test for blood. Gixam results will be compared with a colonoscopy, a test that uses a camera to look inside the colon and rectum.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 45–84 years old.
  • You can sign a form agreeing to join the study.
  • A doctor or other health care provider says you have an average risk of colon and rectal cancer.
  • You have a screening colonoscopy scheduled at the study site.

Who can't join

  • You are having a colonoscopy to check symptoms, or had one in the past 9 years. An exception is a failed test in the past year because the bowel was not clean enough, with no treatment done during that test.
  • You had a positive FIT or FOBT stool blood test in the past 11 months, or a positive Cologuard, Sheild, ColoSense, or Epi proColon test in the past 3 years.
  • You have had colon or rectal cancer; a parent, sibling, or child has had it; or you or your family have a cancer condition passed down through families, such as FAP or Lynch syndrome.
  • You have or have had inflammatory bowel disease, which causes swelling in the gut, including ulcerative colitis or Crohn’s disease.
  • You cannot stick out your tongue, your tongue shakes, or you have a tongue piercing.
  • You had a dental visit in the 7 days before the Gixam test.
  • You took antibiotics, medicines for fungal infections, or probiotics in the 14 days before the Gixam test.
  • You are pregnant, or the study doctor thinks another condition makes you unable to join.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (8)

AL

CA

FL

IL

NY

OH

VA