Evaluating Gixam for detecting precancerous polyps using tongue images

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Daniella Bleistein
• Email: daniella@jubaan.com
• Phone: +972549599353

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.