Clinical trial NCT06895785: Exalt Single-use Duodenoscope Vs Reusable Scope, a Randomized Controlled Trial
Official title: Exalt Single-use Duodenoscope Vs Reusable Scope, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Biliary Diseases
Pancreatic Duct Disorder
Keywords: endoscopic retrograde cholangiopancreatography (ERCP)
duodenoscope
single-use
reusable
biliary disorder
pancreatic duct disorder
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2025-03-26
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of attempts required to achieve successful cannulation of the desired duct
timeFrame: From the time of the ERCP to 7 days post-ERCP per standard of care
Secondary outcomes:
measure: Crossover single to reusable
timeFrame: From the start of the ERCP to the end of procedure
measure: Use of advanced cannulation techniques
timeFrame: From the start of the ERCP to the end of procedure
measure: Performance on ERCP maneuvers
timeFrame: From the start of the ERCP to the end of procedure
measure: Adverse events
timeFrame: From the completion of the ERCP to 7 days post-ERCP per standard of care
measure: Endoscopist-determined ease of use
timeFrame: From the start of the ERCP to the end of procedure
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Neal A Mehta, MD
role: PRINCIPAL_INVESTIGATOR
References: