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Reusable Versus Disposable Duodenoscopes for ERCP

NCT04143698 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2020-06-23

No results posted yet for this study

Summary

The aim of this randomized trial is to evaluate the technical aspects of disposable duodenoscopes and to compare the technical outcomes between the disposable (single-use) and reusable duodenoscopes.

Conditions

  • Endoscopic Retrograde Cholangiopancreatography

Interventions

DEVICE

endoscopic retrograde cholangiopancreatography

The duodenoscope will be passed to the duodenum in the standard fashion. Once the papilla has been identified in the duodenum, cannulation of the desired duct will be performed in the standard fashion, with the type of accessories used left to the discretion of the individual endoscopist performing the procedure. If cannulation is considered difficult, advanced cannulation techniques can be used per standard of care at the discretion of the individual endoscopist. The types of accessories used will be left to the discretion of the individual endoscopist and will be dependent on procedure indication and personal preference. Cross-over to the alternate duodenoscope type can be performed at any time if the desired technical maneuver cannot be performed with the designated duodenoscope.

Sponsors & Collaborators

  • AdventHealth

    lead OTHER

Principal Investigators

  • Shyam Varadarajulu, MD · AdventHealth Orlando

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-24
Primary Completion
2020-03-20
Completion
2020-05-06
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04143698 on ClinicalTrials.gov