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

Recruiting now · Not applicable

Conditions studied: Biliary Diseases, Pancreatic Duct Disorder

In brief

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.

Key facts

Study ID

NCT06895785

Run by

Rush University Medical Center

People needed

100

Starts

2025-02-21

Expected to finish

2030-05-01

Last updated by the study team

2025-03-26

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patients with altered pancreaticobiliary anatomy
• Pregnancy
• Patients with percutaneous transhepatic biliary drainage
• Prior history of ERCP
• Inability to provide informed consent

Where it is running

• Rush University Medical Center — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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