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Completed No phase listed Observational

The Development and Evaluation of a Novel Duodenoscope Assessment Tool

ClinicalTrials.gov ID: NCT04004533

Public ClinicalTrials.gov record NCT04004533. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 27, 2026, 5:48 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04004533
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
AdventHealth
Other
Enrollment
745 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Not listed

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 19, 2019
Primary completion
Oct 30, 2021
Completion
Dec 30, 2021
Last update posted
Feb 16, 2022

2019 – 2021

United States locations

U.S. sites
9
U.S. states
7
U.S. cities
8
Facility City State ZIP Site status
University of Arkansas Little Rock Arkansas 72205 —
Yale University New Haven Connecticut 06520 —
University of Florida Gainesville Florida 32610 —
Center for Interventional Endoscopy Orlando Florida 32803 —
Brigham and Women's Hospital Boston Massachusetts 02115 —
Mount Sinai Hospital New York New York 10029 —
Columbia University New York New York 10032 —
Allegheny Health Pittsburgh Pennsylvania 15212 —
Vanderbilt University Nashville Tennessee 37232 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04004533, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 16, 2022 · Synced Sep 27, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04004533 live on ClinicalTrials.gov.

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