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Evaluation of Artificial Intelligence for Detection of Gastrointestinal Lesions in Endoscopy (EAGLE)
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.
Age
40 - No limit years
Sex
ALL
Healthy Volunteers
No
Israeli-Georgian Medical Research Clinic Healthycore
Tbilisi, Georgia
Sana Klinikum Lichtenberg
Berlin, Germany
Humanitas Mater Domini
Castellanza, Varese, Italy
Humanitas Catania
Catania, Italy
Humanitas Research Hospital
Milan, Italy
H-T. Centrum Medyczne
Tychy, Poland
The Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, Poland
Przychodnia Polskiej Fundacji Gastroenterologii
Warsaw, Poland
University Hospital "Clinico Lozano Blesa" of Zaragoza
Zaragoza, Spain
Start Date
May 10, 2023
Primary Completion Date
November 20, 2023
Completion Date
November 29, 2023
Last Updated
July 3, 2024
985
ACTUAL participants
CADDIE
DEVICE
Lead Sponsor
Odin Medical
Collaborators
NCT04704661
NCT06696768
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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