Evaluation of Gixam's Efficacy Predicting the Presence of Advanced and Non-advanced Colorectal Neoplasia in a FIT Negative Population
Recruiting · NCT07623902 · Interventional (participants receive a specific treatment) · Lead sponsor: Jubaan Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- Has completed Cologuard, Sheild, ColoSense or Epi proColon testing within the preceding three (3) years.
- History of colorectal cancer.
- Family history of colorectal cancer, defined as having one or more first- degree relatives (parent, sibling, or child) with CRC at any age.
- 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.
- Participant has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn's disease.
- Participants with a disability to extend their tongue.
- Participants with tongue tremor.
- Participants with tongue piercing.
- Participants that had a dental visit in the 7 days prior to the Gixam test.
- Participants that have taken antibiotics or anti-fungal medications in the 14 days prior to the Gixam test.
- Participants that have taken anti-inflammatories or probiotics in the 14 days prior to the Gixam test.
- Participant is pregnant.
- Participant has any condition that in the opinion of the Investigator should preclude participation in the study.
Where it is running
5 locations listed across 5 US states.
- Orlando Gastroenterology, PA - Orlando, Florida, United States
- Comprehensive Gastrointestinal Health, LLC - Northbrook, Illinois, United States
- Westchester Putnam Gastro - Carmel, New York, United States
- Great Lakes Gastroenterology Research, LLC - Mentor, Ohio, United States
- Blue Ridge Medical Research - Lynchburg, Virginia, United States