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Brief Title: EAGLE Trial CADDIE Artificial Intelligence Endoscopy
Official Title: Evaluation of Artificial Intelligence for Detection of Gastrointestinal Lesions in Endoscopy (EAGLE)
Study ID: NCT05730192
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.
Minimum Age: 40 Years
Eligible Ages: ADULT, OLDER_ADULT
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
University College Hospital London, London, , United Kingdom
Name: Alessandro Repici, Prof.
Affiliation: Humanitas Research Hospital
Role: PRINCIPAL_INVESTIGATOR