Trials / Completed
CompletedNCT05730192
EAGLE Trial CADDIE Artificial Intelligence Endoscopy
Evaluation of Artificial Intelligence for Detection of Gastrointestinal Lesions in Endoscopy (EAGLE)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 985 (actual)
- Sponsor
- Odin Medical · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CADDIE | 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. |
Timeline
- Start date
- 2023-05-10
- Primary completion
- 2023-11-20
- Completion
- 2023-11-29
- First posted
- 2023-02-15
- Last updated
- 2024-07-03
Locations
9 sites across 5 countries: Georgia, Germany, Italy, Poland, Spain
Source: ClinicalTrials.gov record NCT05730192. Inclusion in this directory is not an endorsement.