The Development and Evaluation of a Novel Duodenoscope Assessment Tool

CompletedOBSERVATIONAL
Enrollment

745

Participants

Timeline

Start Date

May 20, 2019

Primary Completion Date

October 31, 2021

Study Completion Date

December 31, 2021

Conditions
Dudoenoscope Assessment Tool
Interventions
PROCEDURE

Endoscopic retrograde cholangiopancreatography (ERCP)

At the time of each ERCP procedure, information on procedure indication, technical performance of the duodenoscope and adverse events will be collected using a newly designed duodenoscope assessment tool. The duodenoscope assessment tool was developed to measure the technical performance of the duodenoscopes based on three components: passage and positioning at the papilla, performing requisite technical maneuvers and technical features. Each performance component is graded on a scale ranging from 1 to 5 (1 for easy maneuverability, 5 for most difficult maneuverability). Duodenoscope assessment tool also captures data on procedural indications, cannulation success rates and adverse events.

Trial Locations (9)

10029

Mount Sinai Hospital, New York

10032

Columbia University, New York

15212

Allegheny Health, Pittsburgh

32610

University of Florida, Gainesville

32803

Center for Interventional Endoscopy, Orlando

37232

Vanderbilt University, Nashville

72205

University of Arkansas, Little Rock

06520

Yale University, New Haven

02115

Brigham and Women's Hospital, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AdventHealth

OTHER