Evaluation of Gixam's Performance in a FIT Negative Population

November 12, 2024 updated by: Jubaan Ltd.

In the United States, colorectal cancer ranks second to lung cancer as a cause of cancer death and is the third most commonly occurring cancer in both men and women. Colorectal cancer in most cases develops slowly over a period of years, starting with the growth of precancerous polyps on the colon or rectum wall. The slow development of colorectal cancer makes it possible to detect and prevent it entirely by the removal of the precancerous polyps with colonoscopy. To date, there is no screening test, other than colonoscopy, able to detect the precancerous polyps. Gixam is a camera that takes multiple pictures of your tongue and uses artificial intelligence software to predict the presence of precancerous polyps within your colon or rectum that may eventually become cancerous.

The device creates the prediction by comparing the images taken of your tongue with many other images of tongues from healthy patients and patients with a history of precancerous polyps. Patients who have been predicted by Gixam to have precancerous polyps may be more likely to complete colonoscopy at the interval recommended by their physician, potentially reducing the likelihood of developing colorectal cancer.

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 (FIT). This study will compare this prediction to the actual findings of your scheduled standard care colonoscopy and allow researchers to evaluate and improve the Gixam system.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97220
        • Recruiting
        • The Oregon Clinic Gastroenterology-East
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subjects aged 45-85 years.
  2. Able to provide a signed informed consent.
  3. Scheduled for a screening colonoscopy at the investigation site.

Exclusion Criteria:

  1. Undergoing diagnostic colonoscopy for investigation of symptoms.
  2. 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.
  3. History of colorectal cancer.
  4. Family history of colorectal cancer, defined as having one or more first-degree relatives (parent, sibling, or child) with CRC at any age.

  5. Subject 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 are 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.
  6. Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis and/or Crohn's disease.
  7. Subjects with a disability to extend their tongue.
  8. Subjects with tongue piercing.
  9. Dental visit in the past 7 days prior to Gixam test.
  10. Intake of pro-biotics over the past 3 months pre-Gixam test.
  11. Subject has any condition that in the opinion of the Investigator should preclude participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm
All participants will undergo the same study procedures: FIT, Gixam, and colonoscopy
Device: colorectal cancer (CRC) screening
Gixam test
Diagnostic test: colorectal cancer screening
Fecal Immunochemistry Test (FIT)
Procedure: Colonoscopy after bowel cleansing
Standard of care optical colonoscopy for colorectal cancer screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety - number of device related adverse events and serious adverse events
Time Frame: Through study completion, up to 30 days
Number of device related adverse events and serious adverse events
Through study completion, up to 30 days
Efficacy - Gixam's sensitivity and specificity
Time Frame: Through study completion, up to 30 days
Gixam's sensitivity and specificity to predict the presence of colorectal adenoma or sessile serrated lesions (advances and non-advanced) / CRC in a FIT negative population.
Through study completion, up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jubaan Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Estimated)

March 30, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

September 9, 2024

First Submitted That Met QC Criteria

September 22, 2024

First Posted (Actual)

September 25, 2024

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

November 12, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL-1015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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