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NCT04004533 · ClinicalTrials.gov registry record

The Development and Evaluation of a Novel Duodenoscope Assessment Tool

A clinical trial, sponsored by AdventHealth.

Completed
Registry status
745
Enrollment target

NCT04004533: Completed study, sponsored by AdventHealth.

NCT04004533 is a clinical trial that has completed, run by AdventHealth. The registered enrollment target is 745 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04004533 has completed, sponsored by AdventHealth.

COMPLETED
Registry status
745 participants
Enrollment target

Study Summary

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.

Primary Outcome

Assessment of the internal reliability of the duodenoscope assessment tool will be performed, as determined by the Cronbach's coefficient alpha

Interventions

  • PROCEDURE Endoscopic retrograde cholangiopancreatography (ERCP)

Trial Details

FieldValue
Enrollment Target 745 participants
Start Date 2019-05-20
Est. Completion 2021-12-31
AdventHealth

95 total trials

What the finished NCT04004533 record still lists

NCT04004533 is an observational study that tracks outcomes without assigning an intervention. The registered 745 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 1 intervention - of which Endoscopic retrograde cholangiopancreatography (ERCP) is the first listed.

NCT04004533 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04004533 about?

NCT04004533 is a clinical study titled "The Development and Evaluation of a Novel Duodenoscope Assessment Tool". 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 compli...

What is the current status of trial NCT04004533?

This trial is currently completed. The enrollment target is 745 participants. The study started on 2019-05-20. Estimated completion is 2021-12-31.

What interventions are being tested in trial NCT04004533?

The interventions under investigation include: Endoscopic retrograde cholangiopancreatography (ERCP) (PROCEDURE).

Who is sponsoring clinical trial NCT04004533?

This trial is sponsored by AdventHealth, which has 95 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT04004533, the US trial registry maintained by the National Library of Medicine. NCT04004533 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.