💬In plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
💊
What it tests
- colorectal cancer (CRC) screening
- colorectal cancer screening
- Colonoscopy after bowel cleansing
The Oregon Clinic Gastroenterology-East
Portland, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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