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| Name | Class |
|---|---|
| University of Minnesota | OTHER |
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The aim of this study is to evaluate the clinical benefit and safety of using a computer aided detection device, Skout, for real-time polyp detection in colonoscopy procedures with the indication of screening or surveillance. One of the reasons for the development of interval colorectal cancers is polyps missed during colonoscopy. Our hypothesis is that with the aid of Skout, the adenomas detected per colonoscopy will increase, and it is plausible to believe that this increase in detection could reduce the incidence of interval cancers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Routine Colonoscopy | |
| Experimental | Experimental | Routine Colonoscopy with the use of Skout |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computer Aided Detection device | Device | The Computer Aided Detection device, Skout, is designed to help endoscopists detect potential colorectal polyps during colonoscopies. The system performs automated real-time analysis on endoscopic video data to identify potential polyps and produces an informational visual aid around the appropriate sections of the video frames on a display monitor. |
| Measure | Description | Time Frame |
|---|---|---|
| Adenomas per colonoscopy | The total number of adenomas detected divided by the total number of colonoscopies. | At the end of the procedure, 1 day |
| Positive predictive value | The total number of adenomas and serrated lesions detected divided by the total number of extractions. | At the end of the procedure, 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Adenoma detection rate | The percentage of participants aged ≥50 years undergoing first-time screening colonoscopy who have one or more conventional adenomas detected. | At the end of the procedure, 1 day |
| Sessile serrated lesions detected |
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Inclusion Criteria
Participants will be eligible for this study if they are:
Exclusion Criteria
Participants will not be eligible for this study if they:
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| Name | Affiliation | Role |
|---|---|---|
| Aasma Shaukat, MD, MPH | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Boston Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35643173 | Derived | Shaukat A, Lichtenstein DR, Somers SC, Chung DC, Perdue DG, Gopal M, Colucci DR, Phillips SA, Marka NA, Church TR, Brugge WR; SKOUT Registration Study Team. Computer-Aided Detection Improves Adenomas per Colonoscopy for Screening and Surveillance Colonoscopy: A Randomized Trial. Gastroenterology. 2022 Sep;163(3):732-741. doi: 10.1053/j.gastro.2022.05.028. Epub 2022 May 25. |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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The total number of polyps with histology or serrated adenoma, traditional serrated adenoma or serrated lesion with cytological dysplasia, excluding hyperplastic polyps.
| At the end of the procedure, 1 day |
| Colorectal cancer surveillance interval | The mean recommended timeframe for follow up colonoscopy. | At the end of the procedure, 1 day |
| Boston |
| Massachusetts |
| 02118 |
| United States |
| Mount Auburn Hospital | Cambridge | Massachusetts | 02138 | United States |
| MNGI Digestive Health | Plymouth | Minnesota | 55446 | United States |
| Concord Endoscopy Center | Concord | New Hampshire | 03301 | United States |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |