Study Stopped
Investigator did not move forward with the project due to costs.
Reusable Duodenoscope Culture Registry
Registry of Culture Results From Reusable Duodenoscopes
1 other identifier
observational
N/A
1 country
1
Brief Summary
This project is being performed to examine the results of duodenoscope cultures following standard of care cleaning and reprocessing.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2019
CompletedFirst Posted
Study publicly available on registry
December 24, 2019
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2021
CompletedMarch 14, 2022
February 1, 2022
6 months
December 23, 2019
February 25, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Interventions
Culture of reusable duodenoscopes following each use.
Eligibility Criteria
The data will be collected from patient who have a endoscopic retrograde cholangiopancreatography procedure at the Center for Interventional Endoscopy.
You may qualify if:
- years of age or greater
- Any patient undergoing endoscopic retrograde cholangiopancreatography procedure using a reusable duodenoscope
You may not qualify if:
- Less than 18 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AdventHealthlead
Study Sites (1)
Center for Interventional Endoscopy
Orlando, Florida, 32803, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Shyam Varadarajulu, MD
AdventHealth Orlando
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2019
First Posted
December 24, 2019
Study Start
July 1, 2020
Primary Completion
December 31, 2020
Study Completion
April 30, 2021
Last Updated
March 14, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share