CompletedNot Applicable

Comparison of Duodenoscope With Single-use Distal Cover and the Conventional Reusable Duodenoscope

United States319 participantsStarted 2022-10-25

Plain-language summary

The purpose of the study is to compare the success rates of procedure success and complication rates in patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using two types of currently available endoscopes. These are (1) duodenoscope with a Single-use distal cover or (2) a conventional reusable duodenoscope.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients undergoing ERCP for biliary and pancreatic conditions * Age \> 18 years old Exclusion Criteria: * Vulnerable patient groups including pregnant women * Patients who are unable to consent * Patients with known cholangitis * Patients with known Carbapenem-Resistant Enterobacteriaceae (CRE) or any other multi-drug resistant organisms (MDRO) infection * Surgically altered anatomy except for Billroth I

What they're measuring

Number of Participants With Procedure-related Adverse Events

Timeframe: 3 months

Trial details

NCT IDNCT05429203

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-29

Results submitted2025-07-15

View on ClinicalTrials.gov More Biliary Disease trials