Evaluation of Gixam's Performance in a FIT Negative Population

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Colorectal Adenoma Colorectal Cancer (CRC) Colorectal Cancer (CRC) Screening

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All subjects enrolled will undergo the same study procedures and assessments in the following order: FIT, Gixam, and colonoscopy. Gixam is an investigational medical device determined by the FDA to be a nonsignificant risk device. Colonoscopy is the ground-truth (Gixam outcome is compared to colonoscopy findings). Gixam performance will be evaluated and reported per FIT outcome (the primary efficacy endpoint is sensitivity and specificity in a FIT negative population).

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Participant and physician performing colonoscopy will be masked to FIT and Gixam test outcome until colonoscopy procedure us completed.

Study Groups

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Single arm

All participants will undergo the same study procedures: FIT, Gixam, and colonoscopy

Group Type EXPERIMENTAL

colorectal cancer (CRC) screening

Intervention Type DEVICE

Gixam test

colorectal cancer screening

Intervention Type DIAGNOSTIC_TEST

Fecal Immunochemistry Test (FIT)

Colonoscopy after bowel cleansing

Intervention Type PROCEDURE

Standard of care optical colonoscopy for colorectal cancer screening

Interventions

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colorectal cancer (CRC) screening

Gixam test

Intervention Type DEVICE

colorectal cancer screening

Fecal Immunochemistry Test (FIT)

Intervention Type DIAGNOSTIC_TEST

Colonoscopy after bowel cleansing

Standard of care optical colonoscopy for colorectal cancer screening

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No