Evaluation of Gixam's Performance in a FIT Negative Population

Launched by JUBAAN LTD. · Sep 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device called Gixam, which uses pictures of your tongue to help predict the presence of precancerous polyps in your colon or rectum. These polyps can sometimes turn into colorectal cancer, which is a serious health concern. The Gixam device works by comparing your tongue images to those of healthy individuals and those with a history of polyps. If Gixam predicts that you might have precancerous polyps, it could encourage you to get a colonoscopy sooner, which can help prevent cancer by allowing doctors to remove those polyps.

To participate in this study, you need to be between 45 and 85 years old and scheduled for a routine colonoscopy. You should also be able to give your consent to join the study. However, certain health conditions or recent medical history may exclude you from participating, such as a history of colorectal cancer or certain hereditary cancer syndromes. If you join, you will have your tongue photographed by the Gixam device before your scheduled colonoscopy, and the results will be compared with what doctors find during the colonoscopy. This is a chance to help improve the accuracy of Gixam and contribute to better screening methods for colorectal cancer.

Gender

ALL

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.