What this study is
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.
What's being tested
- Gixam System
Intervention · DEVICE
All participant will undergo the Gixam test per device instructions for use
- FIT
Intervention · DIAGNOSTIC TEST
FIT kit will be handed out to the study participant, who will later sample stool at home and mail the specimen to a reference laboratory for analysis.
- Standard of care screening colonoscopy
Intervention · PROCEDURE
All participants will undergo a standard of care screening colonoscopy which serves as the gold truth in this study
Study details
- Sponsor
- Jubaan Ltd.
- Conditions
- CRC Screening · Microbiome
- Enrolling
- 1,436 people
- Starts
- 2026-05-18
- Est. completion
- 2026-12-31
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 45 Years – 84 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
- Positive Cologuard, Sheild, ColoSense or Epi proColon test 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 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (9)
8 openDigestive Health Specialist
Dothan, Alabama, United States
- Dawn Barnes · Contact334-305-2406dbarnes@digestivepros.com
RecruitingEast View Medical Research, LLC
Mobile, Alabama, United States
- Alana Smith Gorcey · Contact251-385-9004asmithgorcey@eastviewmr.com
RecruitingGastro Care Institute
Lancaster, California, United States
- Ruben Vargas · Contact661-520-9944Rvargas@gciav.com
RecruitingOrlando Gastroenterology, PA
Orlando, Florida, United States
- Shivani Sriprashad · Contact407-445-9224shivani.sriprashad@orlandogastropa.com
RecruitingWestchester Putnam Gastro
Carmel, New York, United States
- MarieLucia Salisbury · Contact845 278 5223msalisbury@putnamgi.com
RecruitingNYU Langone Health
New York, New York, United States
- Allyson Yang · Contact(212)-263-0473Allyson.Yang@nyulangone.org
RecruitingGreat Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States
- Christy DeJohn · Contact440-205-1225christyd@greatlakesgastro.net
RecruitingBlue Ridge Medical Research
Lynchburg, Virginia, United States
- Heather Wilson · Contact434-455-8659heather.wilson@gastrocentralva.com
RecruitingComprehensive Gastrointestinal Health, LLC
Northbrook, Illinois, United States
Active, not recruiting
Study team
Sponsor
Jubaan Ltd.
Study ID CL-1009
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.