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The focus of the study is to evaluate impact on Adenomas Per Colonoscopy (APC) with a Computer Aided Detection (CAD) software assisting the gastroenterologist during a colonoscopy procedure.
The details of the proposed study are as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EndoVigilant CAD Software assisted Colonoscopy Procedure | Experimental | The gastroenterologist performing the colonoscopy procedure will be able to observe a standard colonoscopy video on the primary monitor and video augmented by EndoVigilant CAD software on the second monitor. The gastroenterologist will primarily rely on the second monitor but the standard procedure monitor will be always operational and available for maneuvers such as fast insertion, polypectomy etc. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EndoVigilant CAD Software | Device | The CAD software is deep learning algorithm used to aid in the detection of polyps (abnormal tissue growths in the wall of the colon and adenomas (pre-cancerous growths) during colonoscopy. In its current form, the CAD software is installed on a computer system unit that utilizes an an operating system. |
| Measure | Description | Time Frame |
|---|---|---|
| Adenomas Per Colonoscopy | Averaged Adenomas Per Colonoscopy (APC), to determine if the use of CAD software identifies more adenomas per colonoscopy. This will be generated for the entire study as well as each investigator. This prospectively collected data will be compared against APC for same number of past procedures performed without use of EndoVigilant CAD system, both at aggregate and physician level. | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Healthcare | Palo Alto | California | 94304 | United States | ||
| Greenbelt Endoscopy Center |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D003111 | Colonic Polyps |
| D018256 | Adenomatous Polyps |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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|
| Greenbelt |
| Maryland |
| 20706 |
| United States |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |