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

NCT07623902 | Recruiting FDA Device

• 1 other identifier: CL-1009
• Study Type: interventional
• Target: 1,436
• Locations: 1 country
• Sites: 5

Brief 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). The main questions it aims to answer are:

1. 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. 2.Is the use of the Gixam device safe?
3. 3.Undergo the Gixam test
4. 4.Take a FIT at home and ship to a laboratory.
5. 5.Undergo a standard of care screening colonoscopy.

Conditions

CRC Screening; Microbiome

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint

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

  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.

  Through study completion, an average of 30 days

Secondary Outcomes (1)

• Confirmatory Secondary Efficacy Endpoints

  Through study completion, an average of 30 days

Study Arms (1)

Intervention arm

EXPERIMENTAL

All enrolled participants will undergo the same intervention: Gixam test, FIT, and screening colonoscopy

Device: Gixam System; Diagnostic Test: FIT; Procedure: Standard of care screening colonoscopy

Interventions

Gixam System DEVICE

All participant will undergo the Gixam test per device instructions for use

Intervention arm

FIT 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.

Intervention arm

Standard of care screening colonoscopy PROCEDURE

All participants will undergo a standard of care screening colonoscopy which serves as the gold truth in this study

Intervention arm

Eligibility Criteria

• Age: 45 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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.
• 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.

Sponsors & Collaborators

• Jubaan Ltd.: lead

Study Sites (5)

Orlando Gastroenterology, PA

Orlando, Florida, 32835, United States

RECRUITING

Comprehensive Gastrointestinal Health, LLC

Northbrook, Illinois, 60062, United States

RECRUITING

Westchester Putnam Gastro

Carmel, New York, 10549, United States

RECRUITING

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, 44060, United States

RECRUITING

Blue Ridge Medical Research

Lynchburg, Virginia, 24502, United States

RECRUITING

Related Links

• Sponsor website

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 3, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)