A Single-Use Duodenoscope in a Real-World Setting

Completed · Not applicable

Conditions studied: Endoscopic Retrograde Cholangiopancreatography (ERCP)

In brief

This study will assess how the aScope™ Duodeno endoscope performs in procedures that treat problems of the bile and pancreatic ducts.

Key facts

Study ID

NCT04628949

Run by

Ambu A/S

People needed

248

Starts

2021-01-25

Expected to finish

2022-02-28

Last updated by the study team

2022-08-01

Who can join

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

You may qualify if…

• Subject is ≥ 18 years old.
• Subject is indicated and scheduled for an elective, non-emergent ERCP.
• Subject is willing and able to give informed consent and HIPAA authorization.

You may not qualify if…

• Subject has altered pancreaticobiliary anatomy including:
• Billroth II
• Roux-en-Y gastric bypass
• Loop gastric bypass
• Post-Whipple
• Roux-en-Y hepaticojejunostomy
• Subject requires an emergency ERCP (emergent decompression procedure within 6-12 hours of presentation to prevent life-threatening sequelae).
• Subject has any of the following severe co-morbid conditions
• Morbid obesity (BMI ≥ 40)
• Unstable cardiopulmonary conditions
• Severe and uncorrectable coagulopathy
• Severe and uncorrectable thrombocytopenia
• Subject has clinically significant esophageal, pyloric or duodenal strictures.
• Subject has been previously been treated under this investigational plan.
• Subject is pregnant or female with reproductive capability who is unwilling to have a pre-procedure pregnancy test and use birth control.
• Subject is actively taking an anticoagulant or antiplatelet agent other than aspirin.
• Subject, in the opinion of the Investigator, has a severe comorbidity, poor general physical/mental health and/or a condition that will not allow the subject to be a good study candidate.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Southwest Gastroenterology — Oak Lawn, Illinois, United States
• Indiana University, University Hospital — Indianapolis, Indiana, United States
• Mayo Clinic — Rochester, Minnesota, United States
• NYU Langone Health — New York, New York, United States
• Mount Sinai South Nassau — Oceanside, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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