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CRC ScreeningDiagnostics and screeningDeviceDiagnostic testProcedure

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 ↗