Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05735678
Status:
RECRUITING
Last Update Posted:
2023-03-21
First Post:
2023-02-01
Brief Title:
Single-USe Duodenoscopes PErformance Characteristics and Technical Outcomes the SUSPECT Italian Prospective Study
Sponsor:
Istituto Clinico Humanitas
Organization:
Istituto Clinico Humanitas
Study Overview
Official Title:
Single-USe Duodenoscopes PErformance Characteristics and Technical Outcomes the SUSPECT Italian Prospective Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUSPECT
Brief Summary:
Flexible endoscopes are used globally for the diagnosis and treatment of diseases of the GI tract Duodenoscopes used for Endoscopic Retrograde Cholangiopancreatography ERCP in order to treat different biliary and pancreatic disorders have been recently linked to infections transmission following the procedures Given their reusability and their complex design of the tip with a moving metallic component named the elevator these instruments must be reprocessed through high level disinfection HLD in order to prevent the spread of nosocomial infections Even strict adherence to all HLD procedures results in a residual level of potentially infectious microbes In fact the United States Food and Drug Administration FDA postmarket surveillance communication reported duodenoscope culture results demonstrating contamination rates of up to 36 for low and moderate-concern organisms and up to 54 for high-concern organisms in reprocessed conventional duodenoscopes As a consequence at least 20 outbreaks of duodenoscope-transmitted multidrug resistant organism MDRO infections occurred between 2012 and 2015 despite reported compliance with duodenoscope reprocessing guidelines The increasing concern that currents practices of reprocessing reusable duodenoscopes is insufficient has led the FDA to released recommendation suggesting to develope a newly designed duodenoscopes On one hand a way is to generate duodenoscope with disposable components such as a one-use end cap which can be removed and allow access to the components of the elevator and other areas of the duodenoscope for reprocessing On the other hand an alternative is to produce a fully disposable single-use duodenoscope The evident advantage of a single use duodenoscope over disposable components is that it completely eliminates the need for reprocessing and more important the risk of transmitting microbial infection from patient to patient
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None