Exalt Single-use Duodenoscope Vs Reusable Scope, a Randomized Controlled Trial

Not Applicable

Recruiting

• Conditions: Biliary Diseases; Pancreatic Duct Disorder

• Registration Number: NCT06895785
• Lead Sponsor: Rush University Medical Center

Brief Summary

This randomized controlled trial (RCT) is designed to evaluate the new generation Exalt Model disposable duodenoscope compared to the reusable scope in terms of feasibility, ease of use, adverse events, number of crossover events, and infection rates.

Detailed Description

To ensure a safe and high-quality endoscopy, there are multiple disinfection protocols for endoscopes. Side-viewing duodenoscopes with an adjustable accessory device (elevator) contain potential blind spots for debris and bacteria that require specialized cleaning and disinfection methods beyond standard protocols for other endoscopes. It is thought that the duodenoscope's design, persistent postprocedural microbial contamination and biofilm formation make it more prone to cross-contamination5. Gromski et al, found there are documented pathogenic transmissions, which led to harm in multiple patients and centers3. Infection control was likely related to two major components, reusable duodenoscopes and procedural factors related to how the reusable duodenoscopes were reprocessed3. Multidrug-resistant organisms, such as carbapenem-resistant Enterobacteriaceae, that were associated with reusable duodenoscopes lead the FDA to mandate the transition to improved cleaning and disinfection methods or single-use platforms to eliminate infection transmission. One such single-use platform is the Exalt Model D (Boston Scientific, Marlboro, MA), which received FDA approval in 2020 for use of single-use duodenoscopes. Early iterations of the Exalt were used on a case-by-case basis per institution-specific protocols, mainly due to the learning curve involved with using the scope. A new version of Exalt has been released to market in 2023 with modifications that may make it more feasible to use in all settings requiring a duodenoscope. This randomized controlled trial (RCT) is designed to evaluate the new generation Exalt Model disposable duodenoscope compared to the reusable scope in terms of feasibility, ease of use, adverse events, number of crossover events, and infection rates.

Study Timeline

• Study Start: 2025-02-21
• Status Verified: 2025-03
• Study First Submitted: 2025-03-19
• Study First Submitted QC: 2025-03-19
• Last Update Submitted: 2025-03-19
• Study First Posted: 2025-03-26
• Last Update Posted: 2025-03-26
• Primary Completion: 2030-02
• Study Completion: 2030-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• All patients > 18 years old who have biliary or pancreatic duct disorder, based on clinical symptoms and radiological findings at CT or magnetic resonance cholangiopancreatography
• Native papilla

Exclusion Criteria

• Patients with altered pancreaticobiliary anatomy
• Pregnancy
• Patients with percutaneous transhepatic biliary drainage
• Prior history of ERCP
• Inability to provide informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of attempts required to achieve successful cannulation of the desired duct	From the time of the ERCP to 7 days post-ERCP per standard of care	Measure and compare the total number of attempts required to achieve successful cannulation of the desired duct.

Secondary Outcome Measures

Name	Time	Method
Crossover single to reusable	From the start of the ERCP to the end of procedure	The incidence of crossovers from single-use duodenoscope to reusable duodenoscope
Use of advanced cannulation techniques	From the start of the ERCP to the end of procedure	The utilization of advanced cannulation techniques in ERCP procedure
Performance on ERCP maneuvers	From the start of the ERCP to the end of procedure	Subjective ratings on 14 ERCP maneuvers. ("not preferred/neutral/preferred" relative to the reusable duodenoscope endoscopist usually uses in clinical practice), 23 device performance characteristics. (Likert scale of 1 \[not preferred\] to 5 \[comparable with reusable duodenoscope\])
Adverse events	From the completion of the ERCP to 7 days post-ERCP per standard of care	Post- ERCP pancreatitis, post-sphincterotomy bleed, and infection at 72 hours and 7 days post-ERCP procedure per Standard of Care.
Endoscopist-determined ease of use	From the start of the ERCP to the end of procedure	Median overall satisfaction with the single-use duodenoscope during the procedure (Likert scale of 1 \[unsatisfied\] to 10 \[very satisfied\], followed by the option "If you answered ≤ 5, specify reason")

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States