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

Launched by RUSH UNIVERSITY MEDICAL CENTER · Mar 19, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new type of duodenoscope, called the Exalt Model, which is designed to be used only once, compared to a traditional reusable duodenoscope. The goal is to see how easy it is to use, how well it works, and whether it causes any side effects or infections in patients with biliary diseases or pancreatic duct disorders. Researchers want to find out if using a single-use scope is as effective and safe as the reusable one.

To be eligible for this trial, participants need to be at least 18 years old and have specific symptoms related to their biliary or pancreatic duct issues, confirmed by imaging tests like CT scans or MRIs. However, people who have had certain medical conditions, such as altered anatomy in the bile ducts or previous procedures involving the bile duct, cannot participate. If you join the trial, you will be monitored throughout the process to ensure your safety and to gather important information about the two types of scopes being tested.

Gender

ALL

Eligibility criteria

• 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