1436 Participants NeededMy employer runs this trial

Gixam System for Colorectal Cancer Screening

Recruiting at 4 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to evaluate a new device called the Gixam System, which screens for colorectal cancer by detecting pre-cancer or cancer in the colon and rectum. Researchers seek to determine if the Gixam test is effective and safe, particularly for individuals who have had a negative result on a Fecal Immunochemical Test (FIT). Participants will undergo the Gixam test, a home FIT, and a standard colonoscopy for comparison. This study may suit those aged 45-84 who are at average risk for colorectal cancer and are scheduled for a routine colonoscopy.

As an unphased trial, it offers participants the chance to contribute to important research that could enhance early detection methods for colorectal cancer.

Do I need to stop taking my current medications for the trial?

You may need to stop taking certain medications like antibiotics, anti-fungal medications, anti-inflammatories, or probiotics 14 days before the Gixam test. The trial does not specify other medications, so check with the study team for more details.

What prior data suggests that the Gixam device is safe for colorectal cancer screening?

Research has shown that the Gixam System is a non-invasive test using AI technology to detect early signs of colorectal cancer. It targets precancerous growths, known as adenomas, before they develop into cancer. As a non-invasive test, it does not involve surgery or entering the body, thus carrying no direct medical risks.

Specific safety data on side effects or negative reactions related to the Gixam System is not available. The trial is marked as "Not Applicable" in terms of phase, indicating that the treatment is in early testing stages or does not fit into the usual clinical trial phases, often suggesting minimal risk. Additionally, because the Gixam System is non-invasive, it likely has a favorable safety profile, reducing the chance of complications compared to more invasive procedures like colonoscopies.12345

Why are researchers excited about this trial?

Researchers are excited about the Gixam System for colorectal cancer screening because it combines multiple screening methods—Gixam test, FIT (Fecal Immunochemical Test), and colonoscopy—into a single streamlined process. Unlike traditional methods that often rely on just one approach, this system enhances accuracy by cross-verifying results from different tests. This comprehensive strategy could potentially improve early detection rates, catching cancer in its early stages when it's most treatable.

What evidence suggests that the Gixam device is effective for colorectal cancer screening?

Research has shown that the Gixam System might detect early signs of cancer in the colon and rectum, particularly in individuals with a negative Fecal Immunochemical Test (FIT) result. In this trial, all participants will undergo the same intervention, which includes the Gixam test, FIT, and screening colonoscopy. The aim is to detect cancer early, even when other tests might not. While solid evidence on Gixam's effectiveness is still being gathered, the focus remains on its potential to identify cancer that other screenings might miss. This could enhance early detection and treatment options for colorectal cancer.16789

Are You a Good Fit for This Trial?

This trial is for adults aged 45-84 who are at average risk for colorectal cancer and have recently had a negative result on a home stool test (FIT).

Inclusion Criteria

Able to provide a signed informed consent
Considered by a physician or healthcare provider as being of 'average risk' for CRC
I am between 45 and 84 years old.
See 1 more

Exclusion Criteria

Participants with tongue piercing
Participants that had a dental visit in the 7 days prior to the Gixam test
Participant is pregnant
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Testing

Participants undergo the Gixam test, take a FIT at home, and undergo a standard of care screening colonoscopy

4 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after testing

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Gixam System

Trial Overview

The study tests if the new Gixam device can accurately find pre-cancer or cancer in the colon, compared to standard colonoscopy results. All participants will take the Gixam test, do a FIT at home, and get a screening colonoscopy.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Intervention armExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jubaan Ltd.

Lead Sponsor

Trials
3
Recruited
1,600+

Citations

Comparing the effectiveness of competing tests for reducing ...

This pooled analysis of available clinical outcomes data demonstrates that, when compared with no intervention, colonoscopy reduces CRC mortality by 57% ...

Evaluation of Gixam's Performance in a FIT Negative ...

The purpose of this research study is to test the accuracy of the Gixam device in persons that have received a negative outcome on a Fecal Immunochemical Test ( ...

Effectiveness of Colorectal Cancer (CRC) Screening on All ...

We found that biennial FIT, gFOBT, single/5-yearly FS, and 10-yearly colonoscopy screenings reduced CRC-specific mortality significantly.

Close the Screen

Effect of. Colonoscopy Outreach vs Fecal Immunochemical Test Outreach on Colorectal Cancer Screening Completion: A Randomized. Clinical Trial. JAMA, 2017; 318 ...

3. STUDIES OF COLORECTAL CANCER SCREENING - NCBI

The primary end-point for stool-based tests is finding cancer at an early stage. Stool-based tests also have some ability to detect adenomatous polyps; ...

Improving Colorectal Cancer Screening in a Regional Safety ...

The absolute 61.9% CRC screening rate achieved in 2019 at the pre-COVID pandemic peak at Parkland (according the HEDIS definition) exceeded the ...

Geneoscopy's ColoSense® Test Included as a Preferred ...

This update marks the first time a noninvasive RNA-based test has been included in ACS screening guidelines for detecting colorectal cancer and ...

Recommendation: Colorectal Cancer: Screening

Rates of harms from colonoscopy following abnormal flexible sigmoidoscopy results include 20.7 major bleeding events per 10,000 colonoscopies ( ...

Jubaan - AI-Powered Colorectal Cancer Screening | Gixam™

Gixam™ by Jubaan is a non-invasive, AI-powered pre-screening system designed to detect early warning signs of colorectal adenomas — the precursors to colorectal ...