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NCT04210401 Clinical Trial

Reusable Duodenoscope Culture Registry

Endoscopy Clinical Trial

Official title:
Registry of Culture Results From Reusable Duodenoscopes

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT04210401
Other study ID # 1513291
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date April 30, 2021

Study information
Verified date February 2022
Source AdventHealth
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This project is being performed to examine the results of duodenoscope cultures following standard of care cleaning and reprocessing.

Description:

This project is being performed to examine the results of duodenoscope cultures following standard of care cleaning and reprocessing. This information will allow us to elucidate the number of endoscopic procedures that can be performed using a single duodenoscope until microorganisms are cultured from duodenoscopes after standard of care cleaning and reprocessing. This will in turn allow us to improve the delivery of healthcare to patients undergoing endoscopic procedures.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date April 30, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years of age or greater - Any patient undergoing endoscopic retrograde cholangiopancreatography procedure using a reusable duodenoscope Exclusion Criteria: - Less than 18 years of age

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Duodenoscope Culture
Culture of reusable duodenoscopes following each use.

Locations
Country Name City State
United States Center for Interventional Endoscopy Orlando Florida

Sponsors (1)
Lead Sponsor Collaborator
AdventHealth

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Microorganism Growth The aim of this registry is to identify the number of endoscopic procedures that can be performed using reusable duodenoscopes before microorganisms are grown from duodenoscope cultures following standard of care cleaning and reprocessing. This will enable us to identify the maximum number of procedures that can be performed with a single duodenoscope before being sent to the manufacturer to be refurbished. 6 months
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