Colorectal Adenomatous Polyp, Colorectal Cancer, Colorectal Neoplasms
Conditions
Brief summary
This is a prospective, single arm, multi-center clinical investigation aim to demonstrate the efficacy of Gixam in predicting the presence of premalignant colorectal polyps and colorectal cancer (CRC) in a fecal immunochemical test (FIT) positive population.
Detailed description
1. Average risk persons eligible for CRC screening that have received a positive FIT outcome in the past 6 months and are scheduled for a screening colonoscopy at one of the participating centers will be offered to participate in the study. 2. Following the informed consent process, subjects will undergo the Gixam test. 1. A subset of 50 subjects will participate in the repeatability assessment. They will undergo three (3) repetitive Gixam tests one after the other, by the same operator. 2. Both the subject and the endoscopist will be blinded to the Gixam outcome 3. All subjects will thereafter undergo a standard of care HD-WL colonoscopy procedure. 4. All resected and retrieved lesions will be sent separately for histopathological evaluation.
Interventions
DEVICEGixam System
Jubaan's Gixam System is designed to predict the likelihood of colorectal adenomas or SSL by using white light in the 400 to 720 nm range to capture ultra-high-definition images of the of the tongue and analyzing the spectral signature of the oral microbiome to predict the presence of colorectal adenomas or SSL with help of artificial intelligence (AI).
Sponsors
Jubaan GmbH
Jubaan Ltd.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
SCREENING
Masking
NONE
Masking description
Participants and physician performing colonoscopy will be blinded to the Gixam outcome
Intervention model description
All enrolled subjects will undergo the Gixam test followed by a standard of care colonoscopy
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects aged ≥50 - ≤80 years. 2. Able to provide a signed informed consent. 3. Underwent FIT screening within the past 6 months with a positive result. 4. Scheduled for a FIT positive screening colonoscopy at investigational site.
Exclusion criteria
1. Has undergone colonoscopy within the past nine (9) years, except for a failed colonoscopy due to poor bowel preparation, which must have been performed within the past year without therapeutic intervention. 2. Personal history of CRC. 3. Family history of CRC, defined as having one or more first-degree relatives (parent, sibling, or child) with CRC at any age. 4. 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. 5. Subject has a diagnosis or personal history of inflammatory bowel disease (IBD) including chronic ulcerative colitis, and/or Crohn's disease, and/or IBD-undefined. 6. Subjects with the disability to extend their tongue. 7. Subjects with tongue piercing. 8. Dental visit in the 7 days prior to the Gixam test. 9. Intake of pro-biotics over the past 3 months pre-Gixam test. 10. Subject has any condition that in the opinion of the Investigator should preclude participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety - number of device related adverse events and serious adverse events | Through study completion, up to 30 days | Number of device related adverse events and serious adverse events |
| Efficacy - Gixam's sensitivity and specificity | Through study completion, up to 30 days | Gixam's sensitivity and specificity to predict the presence of premalignant neoplastic colorectal polyps (advanced premalignant neoplastic lesions/non-advanced premalignant neoplastic lesion) and CRC |
Countries
Netherlands
Contacts
Primary ContactDaniella Bleistein
Outcome results
None listed