Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective, multicenter, single-arm clinical investigation designed to evaluate the accuracy of the Gixamâ„¢ 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 Gixamâ„¢ System and a prediction score will be generated by the Gixamâ„¢ AI model. Subjects will thereafter proceed to their SOC colonoscopy, and the Gixamâ„¢ score will be compare with colonoscopy findings to evaluate its performance.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gixam followed by standard of care colonoscopy | Experimental | This is a single-arm study. All participants will undergo the Gixam test following a standard of care colonoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gixam | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Endpoint - Number of device related adverse events and serious adverse events | 1 day | |
| Primary Efficacy Endpoint - Gixam's diagnostic accuracy | 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). | 14 days (till pathology report is received) |
Not provided
Not provided
Inclusion Criteria:
Males or females
Age: 18-75 years, inclusive
Scheduled for colonoscopy procedure at investigation site subject to one of the below criteria:
Able to comprehend and provide informed consent.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Daniella Bleistein | Jubaan Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States | ||
| Westside GI |
Not provided
| Label | URL |
|---|---|
| Jubaan's website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Gastroenterologist performing standard of care colonoscopy post Gixam test will be blinded to the Gixam prediction score.
Not provided
| New York |
| New York |
| 10019 |
| United States |
| NewYork-Presbyterian / Columbia University Irving Medical Center | New York | New York | 10032 | United States |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |