At a glance
ClinicalIndex Comparison RecordN/ACompleted· 319 enrolled
Drug / intervention
Duodenoscope with single-use distal cover +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating Duodenoscope with single-use distal cover and Conventional duodenoscope for Biliary Disease and 5 related conditions. Completed, enrolled 319 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBiliary Disease, Pancreatic Disease, Choledocholithiasis, Biliary Obstruction, Biliary Tract Neoplasms, Pancreatic Neoplasms
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2023202420252026
First PostedJun 2022
Enrollment StartOct 2022
Primary CompletionJul 2024
TodayJul 2026
First PostedJun 23, 2022
Enrollment StartOct 25, 2022
Primary CompletionJul 29, 2024
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 4.0 years ago
Interventions
Duodenoscope with single-use distal coverdevice
Newer duodenoscope with a single-use distal cover
Conventional duodenoscopedevice
Conventional duodenoscope with standard methods of reprocessing