Colorectal Neoplasms, Gastrointestinal Microbiome
Conditions
Keywords
Artificial Intelligence
Brief summary
This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the accuracy of the Gixam™ System in identifying subjects with colorectal adenomas compared to optical colonoscopy. Subjects arriving for a standard of care colonoscopy at the investigation site will be offered to participate in the study. Following an informed consent process, images of the subjects' tongue will be obtained with the Gixam™ System and a prediction score will be generated by the Gixam™ AI model. Subjects will thereafter proceed to their SOC colonoscopy, and the Gixam™ score will be compare with colonoscopy findings to evaluate its performance.
Interventions
DEVICEGixam
Participants will be required to extend their tongue in the Gixam device. Six images will be obtained and analyzed by the artificial intelligence (AI) model generating a prediction score for the presence of colorectal adenoma.
Sponsors
Jubaan Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Masking description
Gastroenterologist performing standard of care colonoscopy post Gixam test will be blinded to the Gixam prediction score.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males or females 2. Age: 18-75 years, inclusive 3. Scheduled for colonoscopy procedure at investigation site subject to one of the below criteria: 1. Screening - defined as first colonoscopy or consecutive colonoscopy without previous findings, previous colonoscopy performed at least 10 years ago (- 1 year); 2. Patient with finding of colorectal adenoma or sessile serrated polyp in previous colonoscopy (must be documented in patient's medical history). 4. Able to comprehend and provide informed consent.
Exclusion criteria
1. Subject who is not a suitable candidate for a colonoscopy 2. Lynch or Familial Adenomatous Polyposis (FAP) inherited syndromes 3. Current or previous Inflammatory Bowel Disease (IBD - Crohn's, Ulcerative Colitis) of significant duration 4. Patients with a disability to extend their tongue. 5. Patients with tongue piercings.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Endpoint - Number of device related adverse events and serious adverse events | 1 day | — |
| Primary Efficacy Endpoint - Gixam's diagnostic accuracy | 14 days (till pathology report is received) | Gixam's diagnostic accuracy (sensitivity and specificity) of adenomatous colorectal polyps. The Gixam's predictive value will be compared to the patient's colonoscopy + pathology (if any specimens are collected) findings as ground truth on a binary basis (YES/NO for adenomatous and sessile serrated polyps). |
Countries
United States
Outcome results
None listed