An interventional study of Exalt Model D and Reusable in Biliary Diseases and Pancreatic Duct Disorder, sponsored by Rush University Medical Center. Recruiting at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-03-26.
Sponsored by Rush University Medical Center · Not applicable, Interventional, and Other
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.
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.
92 studies on the registry are indexed under Gallbladder Diseases; 19 are open to participants now.
This study's planned enrollment of 100 is above the median of 72 across 59 interventional studies indexed under Gallbladder Diseases.
Browse Gallbladder Diseases studies →Rush University Medical Center is the lead sponsor of 397 studies on the registry; 61 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 26 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Exalt Model D single use duodenoscope will be used for ERCP
Device: Exalt Model D
Standard reusable model of duodenoscope will be used for ERCP
Device: Reusable
Exalt Model D single-use duodenoscope will be used in ERCP
Also known as: Single-use duodenoscope
Standard reusable duodenoscope will be used in ERCP
Number of attempts required to achieve successful cannulation of the desired duct
Measure and compare the total 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
Crossover single to reusable
The incidence of crossovers from single-use duodenoscope to reusable duodenoscope
Time frame: From the start of the ERCP to the end of procedure
Use of advanced cannulation techniques
The utilization of advanced cannulation techniques in ERCP procedure
Time frame: From the start of the ERCP to the end of procedure
Performance on ERCP maneuvers
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 \[comparable with reusable duodenoscope\])
Time frame: From the start of the ERCP to the end of procedure
Adverse events
Post- ERCP pancreatitis, post-sphincterotomy bleed, and infection at 72 hours and 7 days post-ERCP procedure per Standard of Care.
Time frame: From the completion of the ERCP to 7 days post-ERCP per standard of care
Endoscopist-determined ease of use
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")
Time frame: From the start of the ERCP to the end of procedure
Plan to share: Undecided
No publications or documents are linked to this record.
Started Feb 2025 (actual). Primary completion is estimated for Feb 2030, 60 months after the start.
Of 32 non-industry interventional studies with no phase under Gallbladder Diseases, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 26. This study's planned 60 months is above that.
Counting every sponsor, half of 34 studies reached it within 14 months; a quarter within 8 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
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