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

NCT07623902 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1436

Last updated 2026-06-03

No results posted yet for this study

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. 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.

Conditions

  • CRC Screening
  • Microbiome

Interventions

DEVICE

Gixam System

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

DIAGNOSTIC_TEST

FIT

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.

PROCEDURE

Standard of care screening colonoscopy

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

Sponsors & Collaborators

  • Jubaan Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-18
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07623902 on ClinicalTrials.gov