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This study assesses the sensitivity and added benefits of computer-aided detection compared to standard care (white-light) in detecting colon polyps in patients undergoing colonoscopy.
Failure in polyp detection leads to colon cancer after colonoscopy. Artificial intelligence systems allow real-time computer-aided detection of polyps with high-accuracy. This study will compare GI-Genius, a real-time CAD system to standard colonoscopy in terms of how many colonoscopies detect an adenoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real-Time Computer Aided Detection | Experimental |
| |
| Standard Colonoscopy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real-Time Computer Aided Detection | Device | This intervention involves using computer-aided detection using a real-time system (GI-Genius, Medtronic) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adenoma Detection Rate | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Adenomas Per Colon | 1 year | |
| Sessile Serrated Lesion Detection Rate | 1 year | |
| Sessile Serrated Lesions Per Colon |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riverside University Health System | Moreno Valley | California | 92555 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36736437 | Background | Thiruvengadam NR, Cote GA, Gupta S, Rodrigues M, Schneider Y, Arain MA, Solaimani P, Serrao S, Kochman ML, Saumoy M. An Evaluation of Critical Factors for the Cost-Effectiveness of Real-Time Computer-Aided Detection: Sensitivity and Threshold Analyses Using a Microsimulation Model. Gastroenterology. 2023 May;164(6):906-920. doi: 10.1053/j.gastro.2023.01.027. Epub 2023 Feb 2. | |
| 38437999 |
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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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| Stanford Colonoscopy | Procedure | This involves white-light colonoscopy |
|
| 1 year |
| False Neoplasia Rate | 1 year |
| Withdrawal Time | 1 year |
| Derived |
| Thiruvengadam NR, Solaimani P, Shrestha M, Buller S, Carson R, Reyes-Garcia B, Gnass RD, Wang B, Albasha N, Leonor P, Saumoy M, Coimbra R, Tabuenca A, Srikureja W, Serrao S. The Efficacy of Real-time Computer-aided Detection of Colonic Neoplasia in Community Practice: A Pragmatic Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2024 Nov;22(11):2221-2230.e15. doi: 10.1016/j.cgh.2024.02.021. Epub 2024 Mar 2. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |