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

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.

Study Overview

• Status: Recruiting
• Conditions: Disease of Gastrointestinal Tract
• Intervention / Treatment: Device: Single-Use Duodenoscopes

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Alessandro Fugazza, MD; Phone Number: 0039-02-82247021; Email: alessandro.fugazza@humanitas.it
• Study Contact Backup: Name: Alessandro Repici, MD; Phone Number: 0039-02-82247493; Email: alessandro.repici@humanitas.it

Study Locations

• Italy
  • Milano
    • Rozzano, Milano, Italy, 20089
      • Recruiting
      • Department of Gastroenterology, Humanitas Research Hospital
      • Contact: Alessandro Repici, MD; Phone Number: 0039-02-82247493; Email: alessandro.repici@humanitas.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for a clinically indicated ERCP or other duodenoscope-based procedure will be enrolled in the study

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Technical performance	24 months
Procedural performance	24 months

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2023
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: February 1, 2023
• First Submitted That Met QC Criteria: February 9, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 9, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: 2917

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: Yes
• product manufactured in and exported from the U.S.: Yes