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

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 Overview

• Status: Recruiting
• Conditions: Pancreatic Duct Disorder; Biliary Diseases
• Intervention / Treatment: Device: Exalt Model D; Device: Reusable

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Neal A Mehta, MD; Phone Number: 3129428651; Email: neal_a_mehta@rush.edu
• Study Contact Backup: Name: Amanda F Lin; Phone Number: 3125633907; Email: amanda_f_lin@rush.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60607
      • Recruiting
      • Rush University Medical Center
      • Contact: Amanda F Lin; Phone Number: 3125633907; Email: amanda_f_lin@rush.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exalt Model D; Exalt Model D single use duodenoscope will be used for ERCP	Device: Exalt Model D; Exalt Model D single-use duodenoscope will be used in ERCP; Other Names: Single-use duodenoscope
Active Comparator: Standard Reusable; Standard reusable model of duodenoscope will be used for ERCP	Device: Reusable; Standard reusable duodenoscope will be used in ERCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From the time of the ERCP to 7 days post-ERCP per standard of care

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crossover single to reusable	The incidence of crossovers from single-use duodenoscope to reusable duodenoscope	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	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])	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.	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")	From the start of the ERCP to the end of procedure

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Investigators: Principal Investigator: Neal A Mehta, MD, Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2025
• Primary Completion (Estimated): February 1, 2030
• Study Completion (Estimated): May 1, 2030

Study Registration Dates

• First Submitted: March 19, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: endoscopic retrograde cholangiopancreatography (ERCP); duodenoscope; biliary disorder; single-use; reusable; pancreatic duct disorder
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Gallbladder Diseases
• Other Study ID Numbers: RUMC-ORA-24022203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

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.: No