Single-USe Duodenoscopes PErformance Characteristics and Technical Outcomes: the SUSPECT Italian Prospective Study

NCT ID: NCT05735678

Last Updated: 2024-08-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-04
• Study Completion Date: 2025-03-31

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 3.6% for low and moderate-concern organisms and up to 5.4% 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.

Conditions

Disease of Gastrointestinal Tract

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Single-Use Duodenoscopes

Single-Use Duodenoscopes

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 18 years or older
• Willing and able to comply with the study procedures and provide written informed consent to participate in the study
• Schedule for a clinically indicated ERCP or other duodenoscope-based procedure

Exclusion Criteria

• Potentially vulnerable subjects, including, but not limited to pregnant women
• Subjects for whom endoscopic techniques are contraindicated
• Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Gastroenterology, Humanitas Research Hospital

Rozzano, Milano, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Alessandro Repici, MD

Role: CONTACT

alessandro.repici@humanitas.it

0039-02-82247493

Alessandro Fugazza, MD

Role: CONTACT

alessandro.fugazza@humanitas.it

0039-02-82247021

Facility Contacts

Alessandro Repici, MD

Role: primary

alessandro.repici@humanitas.it

0039-02-82247493

Other Identifiers

2917

Identifier Type: -

Identifier Source: org_study_id