NCT04628949 - A Single-Use Duodenoscope in a Real-World Setting | Biotech Hunter

Enrollment

248

Participants

Timeline

Start Date

January 25, 2021

Primary Completion Date

January 27, 2022

Study Completion Date

February 28, 2022

Conditions

Endoscopic Retrograde Cholangiopancreatography (ERCP)

Interventions

DEVICE

aScope™ Duodeno endoscope and aBox™ Duodeno

"The aScope™ Duodeno endoscope is a sterile single-use disposable duodenoscope indicated for endoscopic retrograde cholangiopancreatography (ERCP) procedures.The aScope™ Duodeno endoscope is designed to be used with aBox Duodeno, endoscopic accessories and other ancillary equipment for ERCP procedures.~The aBox Duodeno is the console that is necessary for processing the endoscope camera´s video image, regarding the remote switches and output video and recorder data. The aBox Duodeno is designed to be used with the aScope™ Duodeno endoscope."

Trial Locations (9)

10016

NYU Langone Health, New York

11572

Mount Sinai South Nassau, Oceanside

35294

University of Alabama at Birmingham, Birmingham

44195

Cleveland Clinic Foundation, Cleveland

46202

Indiana University, University Hospital, Indianapolis

55905

Mayo Clinic, Rochester

60523

Southwest Gastroenterology, Oak Lawn

77030

Baylor College of Medicine, Houston

80045

University of Colorado Hospital, Aurora