Evaluating Gixam for detecting precancerous polyps using tongue images

Evaluation of Gixam's Performance in a FIT Negative Population

This study is testing a new device that takes pictures of the tongue to see if it can help find precancerous polyps in the colon or rectum for people aged 45-85 who are going for a screening colonoscopy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 45 Years to 85 Years
• Sex: All
• Sponsor: Jubaan Ltd. (Industry-sponsored)
• Locations: 1 site (Portland, Oregon)
• Trial ID: NCT06612281 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the performance of Gixam, a device that captures images of the tongue to predict the presence of precancerous polyps in the colon or rectum using artificial intelligence. The study targets individuals aged 45-85 who are scheduled for a screening colonoscopy. By comparing tongue images from healthy individuals and those with a history of polyps, the device aims to provide a non-invasive screening method for colorectal cancer. The ultimate goal is to enhance early detection and prevention of colorectal cancer through innovative technology.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 45-85 who are scheduled for a screening colonoscopy.

Not a fit: Patients with a history of colorectal cancer or significant familial risk factors for colorectal cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a non-invasive screening method for early detection of colorectal cancer, potentially saving lives.

How similar studies have performed: While the use of artificial intelligence in medical imaging is gaining traction, this specific approach using tongue images for colorectal cancer screening is novel and has not been extensively tested in prior studies.

Eligibility criteria

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.

Where this trial is running

Portland, Oregon

• The Oregon Clinic Gastroenterology-East — Portland, Oregon, United States (Recruiting)

Study contacts

• Study coordinator: Daniella Bleistein

Conditions Colorectal Adenoma; Colorectal Cancer; Colorectal Cancer Screening; Microbiome; Spectral signature; Artificial intelligence