Global Prospective Case Series Using a Single-Use Duodenoscope

Completed · Not applicable

Conditions studied: Endoscopic Retrograde Cholangiopancreatography

In brief

Confirm procedural performance of the ExaltTM Model D Single-Use Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography (ERCP) and other duodenoscope-based procedures

Key facts

Study ID

NCT04103749

Run by

Boston Scientific Corporation

People needed

551

Starts

2021-03-22

Expected to finish

2023-01-05

Last updated by the study team

2023-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years or older
• Willing and able to comply with the study procedures and provide written informed consent to participate in the study
• Scheduled for a clinically indicated ERCP

You may not qualify if…

• Potentially vulnerable subjects, including, but not limited to pregnant women
• Subjects for whom endoscopic techniques are contraindicated
• Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
• Investigator discretion

Where it is running

• University of California Los Angeles Medical Center — Los Angeles, California, United States
• University of Chicago — Chicago, Illinois, United States
• Indianapolis University Hospital — Indianapolis, Indiana, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• North Shore University Hospital — Manhasset, New York, United States
• Cornell Medical Center — New York, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• The University of Texas Health Science Center at San Antonio — San Antonio, Texas, United States
• Virginia Mason Medical Center — Seattle, Washington, United States
• Metro North Hospital and Health Services — Brisbane, Australia
• St. Michael's Hospital - Unity Health — Toronto, Canada
• Institut Paoli-Calmettes — Marseille, France
• Evangelisches Krankenhaus Düsseldorf — Düsseldorf, North Rhine-Westphalia, Germany
• Prince of Wales Hospital — Hong Kong, Hong Kong
• Asian Institute of Gastroenterology — Hyderabad, Telangana, India
• Apollo Multispeciality Hospitals — Kolkata, West Bengal, India
• Humanitas University — Milan, Italy
• Erasmus University Medical Center of Rotterdam — Rotterdam, Netherlands
• Singapore General Hospital — Singapore, Singapore
• Dr. George Mukhari Academic Hospital — Ga-Rankuwa, South Africa

Full record on ClinicalTrials.gov

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