Exalt Single-use Duodenoscope Vs Reusable Scope, a Randomized Controlled Trial
Sponsored by Rush University Medical Center
About this trial
Last updated a year ago
Study ID
RUMC-ORA-24022203
Status
Recruiting
Type
Interventional
Phase
N/A
Placebo
No
Accepting
19+ Years
All Sexes
Trial Timing
Started a year ago
What is this trial about?
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.
What are the participation requirements?
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