Trials / Completed

CompletedNCT05429203

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

Comparison of Outcomes in Patients Undergoing Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) Using Duodenoscope With Single-use Distal Cover and Conventional Reusable Duodenoscope: A Randomized Controlled Trial

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 319 (actual)

Sponsor: Stanford University · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

The risks associated with the ERCP procedure will be explained to patients who meets the eligibility criteria. Consenting patients will be randomized to undergo Endoscopic retrograde cholangiopancreatography (ERCP) using either (1) a duodenoscope with a Single-use distal cover or (2) a conventional reusable duodenoscope. Assessments will be made during, and immediately after the procedure, then patients will be called after 1 week, 1 month, and 3 months after the procedure to get information about adverse events.

Conditions

Interventions

Type	Name	Description
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

Timeline

Start date: 2022-10-25
Primary completion: 2024-07-29
Completion: 2024-07-29
First posted: 2022-06-23
Last updated: 2025-09-15
Results posted: 2025-09-15

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated device study

Source: ClinicalTrials.gov record NCT05429203. Inclusion in this directory is not an endorsement.