Exalt Single-use Duodenoscope Vs Reusable Scope, a Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
• 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
Locations
United States
Illinois
Rush University Medical Center
RECRUITING
Chicago
Contact Information
Primary
Neal A Mehta, MD
Neal_A_Mehta@rush.edu
3129428651
Backup
Amanda F Lin
amanda_f_lin@rush.edu
3125633907
Time Frame
Start Date: 2025-02-21
Estimated Completion Date: 2030-05
Participants
Target number of participants: 100
Treatments
Experimental: Exalt Model D
Exalt Model D single use duodenoscope will be used for ERCP
Active_comparator: Standard Reusable
Standard reusable model of duodenoscope will be used for ERCP
Related Therapeutic Areas
Sponsors
Leads: Rush University Medical Center