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

Part of paid clinical trials in Orlando, Florida.

Sponsor
Jubaan Ltd.
Study ID
NCT07623902
Status
Recruiting
Apply to this trial

Conditions

  • CRC Screening
  • Microbiome

Eligibility Criteria

Sex
ALL
Age
45 Years - 84 Years
Healthy Volunteers
Not accepted

Interventions

  • Gixam System — DEVICE
    All participant will undergo the Gixam test per device instructions for use
  • 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.
  • 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

Study Details

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.

Key Dates

Start date
May 18, 2026
Status verified
May 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
1,436 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

Arms

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

Primary Outcome Measure

Primary Safety Endpoint [ Time Frame: From enrollment to the end of study at 30 days after ]

Locations (5)

FacilityCityStateZIP
Orlando Gastroenterology, PAOrlandoFlorida32835
Comprehensive Gastrointestinal Health, LLCNorthbrookIllinois60062
Westchester Putnam GastroCarmelNew York10549
Great Lakes Gastroenterology Research, LLCMentorOhio44060
Blue Ridge Medical ResearchLynchburgVirginia24502

Find similar trials in Orlando, FL

By research site
Orlando Gastroenterology, PA· Orlando, FLComprehensive Gastrointestinal Health, LLC· Northbrook, ILWestchester Putnam Gastro· Carmel, NYGreat Lakes Gastroenterology Research, LLC· Mentor, OHBlue Ridge Medical Research· Lynchburg, VA

Related Studies