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

NCT05429203 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 319

Last updated 2025-09-15

Study results available
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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.

Conditions

  • Biliary Disease
  • Pancreatic Disease
  • Choledocholithiasis
  • Biliary Obstruction
  • Biliary Tract Neoplasms
  • Pancreatic Neoplasms

Interventions

DEVICE

Duodenoscope with single-use distal cover

Newer duodenoscope with a single-use distal cover

DEVICE

Conventional duodenoscope

Conventional duodenoscope with standard methods of reprocessing

Sponsors & Collaborators

Principal Investigators

  • Subhas Banerjee, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-25
Primary Completion
2024-07-29
Completion
2024-07-29
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05429203 on ClinicalTrials.gov