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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
985
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.
Israeli-Georgian Medical Research Clinic Healthycore
Tbilisi, Georgia
Sana Klinikum Lichtenberg
Berlin, Germany
Humanitas Mater Domini
Castellanza, Varese, Italy
Humanitas Catania
Catania, Italy
Number of Adenoma per colonoscopy (APC)
Superiority of CADDIE Arm vs. control.
Time frame: During the procedure/surgery
Positive percent agreement (PPA)
Non inferiority of CADDIE Arm vs. control.
Time frame: During the procedure/surgery
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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