Exalt Single-use Duodenoscope Vs Reusable Scope, a Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exalt Model D, Reusable.
- Who it may be relevant to
- Registry conditions: Biliary Diseases, Pancreatic Duct Disorder. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Exalt Model D
Exalt Model D single-use duodenoscope will be used in ERCP - Device Reusable
Standard reusable duodenoscope will be used in ERCP
Primary outcome measures
- Number of attempts required to achieve successful cannulation of the desired duct [Time frame: From the time of the ERCP to 7 days post-ERCP per standard of care]
Secondary outcome measures (5)
- Crossover single to reusable [Time frame: From the start of the ERCP to the end of procedure]
- Use of advanced cannulation techniques [Time frame: From the start of the ERCP to the end of procedure]
- Performance on ERCP maneuvers [Time frame: From the start of the ERCP to the end of procedure]
- Adverse events [Time frame: From the completion of the ERCP to 7 days post-ERCP per standard of care]
- Endoscopist-determined ease of use [Time frame: From the start of the ERCP to the end of procedure]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
United States · 1 center
- Rush University Medical Center — Chicago
Identifiers
NCT: NCT06895785 · RUMC-ORA-24022203