Reusable Duodenoscope Culture Registry

Registry of Culture Results From Reusable Duodenoscopes

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

Study Overview

• Status: Withdrawn
• Conditions: Endoscopy
• Intervention / Treatment: Other: Duodenoscope Culture

Detailed 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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32803
      • Center for Interventional Endoscopy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The data will be collected from patient who have a endoscopic retrograde cholangiopancreatography procedure at the Center for Interventional Endoscopy.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: AdventHealth

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2020
• Primary Completion (ANTICIPATED): December 31, 2020
• Study Completion (ANTICIPATED): April 30, 2021

Study Registration Dates

• First Submitted: December 23, 2019
• First Submitted That Met QC Criteria: December 23, 2019
• First Posted (ACTUAL): December 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 14, 2022
• Last Update Submitted That Met QC Criteria: February 25, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 1513291

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No