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NCT04004533

The Development and Evaluation of a Novel Duodenoscope Assessment Tool

Completed Last updated 17 February 2022
What this trial tests

trial testing Endoscopic retrograde cholangiopancreatography (ERCP) in Dudoenoscope Assessment Tool in 745 participants. Completed in 31 December 2021.

Timeline
20 May 2019
Primary endpoint
31 October 2021
31 December 2021

Quick facts

Lead sponsorAdventHealth
StatusCompleted
Study typeOBSERVATIONAL
Enrollment745
Start date20 May 2019
Primary completion31 October 2021
Estimated completion31 December 2021
Sites9 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

AdventHealth — full company profile →

Who can join

18 and older, any sex, with Dudoenoscope Assessment Tool. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Endoscopic retrograde cholangiopancreatography (ERCP) procedures are performed using duodenoscopes for the treatment of pancreatic and biliary diseases. Although outcomes in endoscopic retrograde cholangiopancreatography (ERCP) procedures are measured mainly in terms of procedural success and complications, currently there are no objective tools to assess the technical performance of the duodenoscopes. The Center for Interventional Endoscopy has maintained a multicenter database that prospectively evaluates the technical performance of duodenoscopes for performing ERCPs. Our objective is to analyze the database in order to summarize the technical performance of duodenoscopes during ERCPs and evaluate the reliability of the duodenoscope assessment tool.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Prospective evaluation of an assessment tool for technical performance of duodenoscopes.
    Bang JY, Rösch T, Kim HM, Thakkar S, et al · · 2021 · cited 7× · PMID 33007136 · DOI 10.1111/den.13856

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Other trials of Endoscopic retrograde cholangiopancreatography (ERCP)

Trials testing the same drug.

Other AdventHealth trials

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04004533.

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