Exalt Single-use Duodenoscope Vs Reusable Scope, a Randomized Controlled Trial
Launched by RUSH UNIVERSITY MEDICAL CENTER · Mar 19, 2025
Trial Information
Current as of April 22, 2025
Recruiting
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
Trial Officials
Neal A Mehta, MD
Principal Investigator
Rush University Medical Center
About Rush University Medical Center
Rush University Medical Center is a leading academic medical institution located in Chicago, Illinois, dedicated to advancing healthcare through innovative research and clinical trials. As a sponsor of numerous clinical studies, Rush focuses on translating scientific discoveries into effective treatments and improving patient outcomes across a variety of medical disciplines. With a commitment to excellence in patient care, education, and research, Rush leverages its state-of-the-art facilities and a robust network of specialists to conduct comprehensive trials that adhere to the highest ethical and regulatory standards. Through collaboration with a diverse patient population, Rush aims to enhance the understanding of diseases and develop novel therapeutic strategies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Chicago, Illinois, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported