Clinical trial · Interventional
EAGLE Trial CADDIE Artificial Intelligence Endoscopy
Evaluation of Artificial Intelligence for Detection of Gastrointestinal Lesions in Endoscopy (EAGLE)
NCT05730192CI-TRIAL-00078470EAGLEcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenoma Colon | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Polyp of Colon | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CADDIE | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CADDIE colonoscopy (CADDIE Arm)
- description
- CADDIE is a computer-assisted detection (CADe) device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract.
- interventionNames
- Device: CADDIE
- type
- ACTIVE_COMPARATOR
- label
- Standard high-definition white light colonoscopy (Control Arm)
- description
- Patients will receive a standard colonoscopy
- interventionNames
- Device: CADDIE
Primary outcomes (2)
- measure
- Number of Adenoma per colonoscopy (APC)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. Screening or surveillance colonoscopy 2. Age 40 years or older 3. Informed consent Exclusion Criteria: 1. Emergency colonoscopies 2. Inflammatory bowel disease (IBD) 3. Colorectal Cancer (CRC) 4. Previous Colorectal Cancer (CRC) 5. Previous colonic resection 6. Returning for a planned elective therapeutic colonoscopy. 7. Polyposis syndromes (familial adenomatous polyposis) 8. Contraindication for biopsy or polypectomy.
References
Publications (1)
- DERIVEDKader 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. PMID 41449203