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The goal of this clinical trial is to evaluate the diagnostic yield of CADe in a consecutive population undergoing colonoscopy. The main question it aims to answer is the Adenoma Detection Rate (ADR). Participants undergoing colonoscopy will be randomized in a 1:1 ratio to either receive Computer-Aided Detection (CADe) colonoscopy or a conventional colonoscopy (CC). Researchers will compare the CADe group and the CC-group to see if CAD-e can increase the ADR significantly.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CADe Colonoscopy | Experimental | Colonoscopy with the help of CADe system (ENDO-Aid) |
|
| Conventional Colonoscopy | No Intervention | Standard Colonoscopy with white light |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENDO-Aid by Olympus | Device | Colonoscopy assisted by ENDO-AID device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adenoma detection rate (ADR) | ADR defined as the proportion of patients with at least 1 adenoma detected. | 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Polyp detection rate (PDR) | PDR defined as the proportion of patients with at least 1 polyp detected. | 1 years |
| Polyp per colonoscopy (PPC) | PPC defined as total number of polyps resected divided by the total number of colonoscopies. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Poliambulanza | Brescia | Bs | 25124 | Italy | ||
| Policlinico Universitario Agostino Gemelli |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39814659 | Derived | Spada C, Salvi D, Ferrari C, Hassan C, Barbaro F, Belluardo N, Grazioli LM, Milluzzo SM, Olivari N, Papparella LG, Pecere S, Pesatori EV, Petruzziello L, Piccirelli S, Quadarella A, Cesaro P, Costamagna G. A comprehensive RCT in screening, surveillance, and diagnostic AI-assisted colonoscopies (ACCENDO-Colo study). Dig Liver Dis. 2025 Mar;57(3):762-769. doi: 10.1016/j.dld.2024.12.023. Epub 2025 Jan 14. |
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| 1 years |
| Adenoma per colonoscopy (APC) | APC defined as total number of histologically confirmed adenomas resected divided by the total number of colonoscopies. | 1 years |
| Sessile serrated lesion detection rate (SSLDR) | SSLDR percentage of patients who have 1 or more histologically confirmed sessile serrated lesion resected divided by the total number of colonoscopies. | 1 years |
| Advanced adenoma detection rate (AADR) | AADR Adenomas are classified as advanced with a size >= 10mm and/or a (tubulo)villous histology and/or high-grade dysplasia (HGD) | 1 years |
| Roma |
| 00168 |
| Italy |