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| Name | Class |
|---|---|
| Meditrial Europe Ltd. | INDUSTRY |
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The EAGLE study is a prospective randomized controlled multicenter parallel design trial, for the assessment of clinical performance of the CADDIE device and to confirm that the device performs as expected.
The EAGLE study will be conducted with a parallel design. Patients who meet the study inclusion/exclusion criteria will be randomized in a 1:1 ratio to receive either computer-aided colonoscopy (CADDIE Arm) using CADDIE or standard colonoscopy without CADe (Control Arm). All resected polyps will be submitted for histologic examination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CADDIE colonoscopy (CADDIE Arm) | Experimental | CADDIE is a computer-assisted detection (CADe) device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. |
|
| Standard high-definition white light colonoscopy (Control Arm) | Active Comparator | Patients will receive a standard colonoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CADDIE | Device | A colonoscopy is an examination of the bowels using a colonoscope, or a thin, flexible tube with a light and camera. It can help identify issues like colorectal cancer, polyps, and ulcers. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adenoma per colonoscopy (APC) | Superiority of CADDIE Arm vs. control. | During the procedure/surgery |
| Positive percent agreement (PPA) | Non inferiority of CADDIE Arm vs. control. | During the procedure/surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alessandro Repici, Prof. | Humanitas Research Hospital IRCCS, Rozzano-Milan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Israeli-Georgian Medical Research Clinic Healthycore | Tbilisi | Georgia | ||||
| Sana Klinikum Lichtenberg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41449203 | Derived | Kader R, Hassan C, Lanas A, Romanczyk M, Romanczyk T, Kotowski B, Homedes CS, Mangiavillano B, Bonanno G, Lovat LB, Kaminski M, Faiss S, Repici A. A novel cloud-based artificial intelligence for real-time detection of colorectal neoplasia - a randomized controlled trial (EAGLE). NPJ Digit Med. 2025 Dec 26;9(1):84. doi: 10.1038/s41746-025-02270-1. |
| Label | URL |
|---|---|
| Meditrial Clinical Research Organization | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 16, 2026 | |
| Reset | Mar 6, 2026 | |
| Release | Mar 17, 2026 | |
| Reset | Apr 6, 2026 | |
| Release | Apr 13, 2026 | |
| Reset | May 1, 2026 | |
| Release | May 14, 2026 | |
| Reset | Jun 9, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 16, 2026 | Mar 6, 2026 | |||
| Mar 17, 2026 |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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Parallel trial design
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Histology of the polyps is performed by the pathologist blinded to the study group assignment.
|
| Berlin |
| Germany |
| Humanitas Mater Domini | Castellanza | Varese | 21100 | Italy |
| Humanitas Catania | Catania | 95045 | Italy |
| Humanitas Research Hospital | Milan | 20089 | Italy |
| H-T. Centrum Medyczne | Tychy | 43-100 | Poland |
| The Maria Sklodowska-Curie National Research Institute of Oncology | Warsaw | 00-001 | Poland |
| Przychodnia Polskiej Fundacji Gastroenterologii | Warsaw | 00-631 | Poland |
| University Hospital "Clinico Lozano Blesa" of Zaragoza | Zaragoza | Spain |
| Odin Vision Cloud Connected Endoscopy | View source |
| Apr 6, 2026 |
| Apr 13, 2026 | May 1, 2026 |
| May 14, 2026 | Jun 9, 2026 |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |