Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-26 @ 4:14 AM
Study NCT ID:
NCT05730192
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2023-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EAGLE Trial CADDIE Artificial Intelligence Endoscopy
Sponsor:
Odin Medical
Organization:
Study Overview
Official Title:
Evaluation of Artificial Intelligence for Detection of Gastrointestinal Lesions in Endoscopy (EAGLE)
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EAGLE
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: