CRC ScreeningNCT07623902
Evaluation of Gixam's Efficacy Predicting the Presence of Advanced and Non-advanced Colorectal Neoplasia in a FIT Negative Population
A study testing Gixam System and FIT in people with CRC Screening and Microbiome, run by Jubaan Ltd. at 9 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 45 to 84 years
- Conditions the study is for
- CRC Screening, Microbiome
- What is being tested?
- Gixam System and FIT
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,436 participants
- Where
- 9 sitesUnited States
- Study dates
- 18 May 2026to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 8 recruiting
- Recruiting
Westchester Putnam Gastro
Carmel, New York, 10549
MarieLucia Salisbury, 845 278 5223, msalisbury@putnamgi.com
- Recruiting
Digestive Health Specialist
Dothan, Alabama, 36301
Dawn Barnes, 334-305-2406, dbarnes@digestivepros.com
- Recruiting
Gastro Care Institute
Lancaster, California, 93534
Ruben Vargas, 661-520-9944, Rvargas@gciav.com
- Recruiting
Blue Ridge Medical Research
Lynchburg, Virginia, 24502
Heather Wilson, 434-455-8659, heather.wilson@gastrocentralva.com
- Recruiting
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060
Christy DeJohn, 440-205-1225, christyd@greatlakesgastro.net
- Recruiting
East View Medical Research, LLC
Mobile, Alabama, 36606
Alana Smith Gorcey, 251-385-9004, asmithgorcey@eastviewmr.com
- Recruiting
NYU Langone Health
New York, New York, 10016
Allyson Yang, (212)-263-0473, Allyson.Yang@nyulangone.org
- Active, not recruiting
Comprehensive Gastrointestinal Health, LLC
Northbrook, Illinois, 60062
- Recruiting
Orlando Gastroenterology, PA
Orlando, Florida, 32835
Shivani Sriprashad, 407-445-9224, shivani.sriprashad@orlandogastropa.com
About this study
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:
- 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?
- Is the use of the Gixam device safe?
Read more
Gixam test result will be compared to the findings of a standard of care screening colonoscopy.
Study participants will:
- Undergo the Gixam test
- Take a FIT at home and ship to a laboratory.
- Undergo a standard of care screening colonoscopy.
- Conditions
- CRC Screening, Microbiome
- Being tested
- Gixam System, FIT, Standard of care screening colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gixam SystemDevice
All participant will undergo the Gixam test per device instructions for use
FITDiagnostic 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 colonoscopyProcedure or surgery
All participants will undergo a standard of care screening colonoscopy which serves as the gold truth in this study
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | All enrolled participants will undergo the same intervention: Gixam test, FIT, and screening colonoscopy Receives: Device: Gixam System; Diagnostic Test: FIT; Procedure: Standard of care screening colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Endpoint
Number of device-related adverse events and serious adverse events.
Measured: From enrollment to the end of study at 30 days after
Primary Efficacy Endpoints
Sensitivity and specificity of Gixam in participants with a negative FIT result.
Measured: Through study completion, an average of 30 days
Secondary outcomes (1)
Confirmatory Secondary Efficacy Endpoints
Standalone sensitivity and specificity of Gixam in general average risk population.
Measured: Through study completion, an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start18 May 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRC ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,436 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jubaan Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623902
- Sponsor's protocol ID
- CL-1009
- Status last verified
- Oct 2026
- First submitted
- 21 May 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No