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Evaluating the Gixam System for Colorectal Cancer Screening

This study is testing a new device called the Gixam System. It aims to see if Gixam can find pre-cancerous growths or cancer in the colon and rectum in adults aged 45 to 84 who are at average risk for colorectal cancer and have already had a negative (normal) result on a FIT (Fecal Immunochemical Test). Researchers want to know if the Gixam System is effective at finding these growths and if it is safe to use. Your Gixam test results will be compared to the findings from a standard colonoscopy, which is considered the most accurate test in this study. The study is currently unclear on its recruitment status and plans to enroll 1436 participants.

Study design
This is an interventional study that plans to enroll 1436 participants. All participants will undergo the Gixam test, a FIT, and a standard screening colonoscopy.
What's involved
You will undergo the Gixam test, take a FIT at home and mail it to a lab, and have a standard screening colonoscopy.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored from enrollment until 30 days after the study ends. Efficacy (how well the Gixam device works) will be measured through study completion, an average of 30 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07623902

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

Recruiting
NAAges 45–84InterventionalScreening
Jubaan Ltd.
~1,436 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:Gixam SystemFITStandard of care screening colonoscopy

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Safety Endpoint
Measured over From enrollment to the end of study at 30 days after
+1 more outcome measured

Conditions

CRC Screening
Microbiome

Explore related trials

Colorectal Neoplasm

NCT07623902

Where you'd take part

This study runs at 5 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Blue Ridge Medical Research

    Lynchburg, Virginiastudy coordinator listed

    Recruiting

  • Comprehensive Gastrointestinal Health, LLC

    Northbrook, Illinoisstudy coordinator listed

    Recruiting

  • Great Lakes Gastroenterology Research, LLC

    Mentor, Ohiostudy coordinator listed

    Recruiting

  • Orlando Gastroenterology, PA

    Orlando, Floridastudy coordinator listed

    Recruiting

  • Westchester Putnam Gastro

    Carmel, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Shivani Sriprashad
[email protected]
407-445-9224
Email the study team

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Eligibility criteria

Exclusion

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 anti-inflammatories or 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.

What this trial measures

  • Primary Safety EndpointFrom enrollment to the end of study at 30 days after

    Number of device-related adverse events and serious adverse events.

  • Primary Efficacy EndpointsThrough study completion, an average of 30 days

    Sensitivity and specificity of Gixam in participants with a negative FIT result.