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The goal of this clinical trial is to determine whether using artificial intelligence (AI) can improve the detection and characterization of abnormal growths (polyps) during colonoscopy in adults aged 50 to 74 years who are undergoing colorectal cancer screening after a positive stool test.
The main questions it aims to answer are:
Researchers will compare colonoscopies performed with AI assistance (using the CAD EYEâ„¢ system) to standard colonoscopies without AI to see if AI improves detection rates or diagnostic accuracy.
Participants will:
This study helps evaluate whether AI can make colonoscopies more effective and reduce unnecessary polyp removals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional colonoscopy without AI assistance | No Intervention | ||
| AI-assisted colonoscopy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial Intelligence-Assisted Colonoscopy | Diagnostic Test | The intervention involves the use of an artificial intelligence tool during screening colonoscopy. This system includes two integrated functions:
The AI system operates autonomously during the procedure and displays visual cues on the monitor to support the endoscopist in detecting and characterizing colorectal lesions. |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the adenoma detection rate (ADR) and advanced colorectal neoplasia detection rate between conventional colonoscopy and AI-assisted colonoscopy. | During the screening colonoscopy visit (single time point assessment on the day of the procedure). |
| Measure | Description | Time Frame |
|---|---|---|
| To compare mean number of lesions between conventional colonoscopy and AI-assisted colonoscopy. | During the screening colonoscopy visit (single time point assessment on the day of the procedure). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Care Complex of Palencia | Palencia | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41854124 | Derived | Robles de la Osa D, Santos Fernandez J, Perez Urra C, Espinel Pinedo P, Bulnes Labrador CB, Martin Ibanez C, Gonzalez de Castro E, Perez Citores L, Montero Moreton AM, Santos Santamarta F, Cimavilla Roman M, Moreira da Silva BA, Maestro Antolin S, Barcenilla Laguna J, Rancel Medina FJ, Rizzo Rodriguez MA, Lopez Allue L, Perez Millan AG. Efficacy of an artificial intelligence system for lesion detection and characterization (CADe and CADx) during colonoscopy following positive faecal immunochemical test in a colorectal cancer screening programme: A randomized clinical trial. Colorectal Dis. 2026 Mar;28(3):e70426. doi: 10.1111/codi.70426. |
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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 |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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