Status:
RECRUITING
Exalt Single-use Duodenoscope Vs Reusable Scope, a Randomized Controlled Trial
Lead Sponsor:
Rush University Medical Center
Conditions:
Biliary Diseases
Pancreatic Duct Disorder
Eligibility:
All Genders
19+ years
Phase:
NA
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 event...
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...
Eligibility Criteria
Inclusion
- 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
- Patients with altered pancreaticobiliary anatomy
- Pregnancy
- Patients with percutaneous transhepatic biliary drainage
- Prior history of ERCP
- Inability to provide informed consent
Key Trial Info
Start Date :
February 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2030
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06895785
Start Date
February 21 2025
End Date
May 1 2030
Last Update
March 26 2025
Active Locations (1)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60607