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Business decision to discontinue the study. Discontinuation is not related to any patient safety or performance issues.
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| Name | Class |
|---|---|
| Meditrial USA Inc. | INDUSTRY |
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Ultivision AI is a computer-assisted detection (CADe) device intended to aid endoscopists in the real-time identification of colonic mucosal lesions (such as polyps and adenomas).
Ultivision AI CADe is indicated for white light colonoscopy only.
Ultivision AI contains an image processing software and algorithm based on machine learning technology and convolutional neural networks (CNN).
The algorithm's primary function is to identify and highlight the likelihood of the presence of a colon polyp.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultivision AI colonoscopy (CADe Arm) | Experimental | Ultivision AI is used to aid in real-time detection of adenomas. |
|
| Standard colonoscopy (Control Arm) | Active Comparator | Patients will undergo standard colonoscopy without AI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultivision AI | Device | Ultivision AI is a computer-assisted detection (CADe) device intended to aid endoscopists in the real-time identification of colonic mucosal lesions (such as polyps and adenomas) in adult patients undergoing colorectal cancer screening and surveillance examinations. |
| Measure | Description | Time Frame |
|---|---|---|
| Adenoma per Colonoscopy (APC) | Superiority of Ultivision-AI arm versus control arm. APC is defined as the total number of histologically confirmed adenomas resected divided by the total number of colonoscopies. | During the procedure/surgery |
| Adenoma Per Extraction (APE). | Non inferiority of Ultivision-AI arm versus control arm. Where APE is the fraction of adenoma, sessile serrated lesions, and large (>10mm) hyperplastic polyps of the proximal colon (caecum, ascending colon, hepatic flexure, and transverse colon) out of total number of resections. | During the procedure/surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Irvine | Irvine | California | 92697 | United States | ||
| University of Kansas Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29928897 | Result | Urban G, Tripathi P, Alkayali T, Mittal M, Jalali F, Karnes W, Baldi P. Deep Learning Localizes and Identifies Polyps in Real Time With 96% Accuracy in Screening Colonoscopy. Gastroenterology. 2018 Oct;155(4):1069-1078.e8. doi: 10.1053/j.gastro.2018.06.037. Epub 2018 Jun 18. |
| Label | URL |
|---|---|
| Satisfai Health | View source |
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Parallel trial design
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Pathologist is blind to group assignment
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| Kansas City |
| Kansas |
| 66160 |
| United States |
| University of Montreal Research Center (CRCHUM) | Montréal (Québec) | Montreal | H2X 0A9 | Canada |
| Humanitas Research Hospital | Milan | Italy |
| Meditrial Clinical Research Organization | View source |