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The purpose of this project is to examine the role of machine learning and computer aided diagnostics in automatic polyp detection and to determine in real-time how a computer-aided detection (CADe) algorithm will perform when compared to standard screening or surveillance colonoscopy alone. Design will be a multi-center, prospective, unblinded randomized tandem colonoscopy study. 196 patients referred for either screening or surveillance colonoscopy will be included.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Technique followed by Combination | Active Comparator | Back-to-back tandem colonoscopies by the same endoscopist using an Olympus 190 colonoscope. The first colonoscopy will be performed without automated polyp detection software (standard technique) followed immediately by another colonoscopy with automated polyp detection software (combination technique). |
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| Combination +followed by Standard Technique | Active Comparator | Back-to-back tandem colonoscopies by the same endoscopist using an Olympus 190 colonoscope. In this arm, the first colonoscopy with be performed with automated polyp detection software (combination technique) followed immediately by another colonoscopy without automated polyp detection software (standard technique) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard technique First | Diagnostic Test | colonoscopy without automated polyp detection software |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of adenomas detected in combination technique compared to adenomas detected in standard technique Measured by Adenoma Miss Rate (AMR) | AMR will be calculated as the number of adenomas detected on the second pass or portion in either group divided by the total number of adenomas detected during both passes. | 1 Year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seth Gross, MD | New York Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
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| ID | Term |
|---|---|
| D003108 | Colonic Diseases |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| combination technique First | Diagnostic Test | automated polyp detection software |
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