Reusable Duodenoscope Culture Registry | NCT04210401

Studies
Reusable Duodenoscope Culture Registry

NCT04210401

Sponsor

AdventHealth

Status

Withdrawn

Last Update Posted

Mar 14, 2022Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Endoscopy

Interventions

Duodenoscope Culture

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Investigator did not move forward with the project due to costs.

Expanded Access Info

Start Date

Jul 1, 2020Estimated

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Apr 30, 2021Estimated

First Submitted Date

Dec 23, 2019

First Submission Date that Met QC Criteria

Dec 23, 2019

First Posted Date

Dec 24, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 25, 2022

Last Update Posted Date

Mar 14, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Duodenoscope Culture	Other	Culture of reusable duodenoscopes following each use.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shyam Varadarajulu, MD	AdventHealth Orlando	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Interventional Endoscopy		Orlando	Florida	32803	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided