Actively Recruiting
Exalt Single-use Duodenoscope Versus Reusable Scope in Patients with Biliary or Pancreatic Duct Disorders: A Randomized Controlled Trial
Led by Rush University Medical Center ยท Updated on 2025-03-26
100
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare a new single-use duodenoscope called the Exalt Model D with the standard reusable duodenoscope in patients who need endoscopic retrograde cholangiopancreatography (ERCP) for biliary or pancreatic duct disorders. The study focuses on how feasible and easy the new device is to use, along with monitoring adverse events, crossover events between devices, and infection rates. This is a randomized controlled trial designed to address concerns about infection risks linked to reusable duodenoscopes due to their complex design and cleaning challenges. Participants will be randomly assigned to use either the Exalt Model D single-use duodenoscope or the standard reusable duodenoscope during ERCP procedures. The trial will assess the number of attempts required to successfully reach the targeted duct, use of advanced cannulation techniques, performance on ERCP maneuvers, and the endoscopist's rating of ease of use. Adverse events will be tracked from the procedure through seven days post-ERCP, following standard care protocols. During the study, researchers will observe and record the outcomes related to device performance and safety up to seven days after the procedure. Participants' eligibility is based on clinical symptoms and imaging findings of biliary or pancreatic duct disorders and having a native papilla. The study is sponsored by Rush University Medical Center and will begin in February 2025, continuing until May 2030. Participants will be closely monitored for any complications or infections related to the duodenoscope used.
CONDITIONS
Brief Title
Exalt Single-use Duodenoscope Vs Reusable Scope, a Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients older than 18 years
- Diagnosis of biliary or pancreatic duct disorder based on clinical symptoms and CT or magnetic resonance cholangiopancreatography
- Presence of native papilla
You will not qualify if you...
- Altered pancreaticobiliary anatomy
- Pregnancy
- Presence of percutaneous transhepatic biliary drainage
- Prior history of ERCP
- Inability to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of ERCP procedure
Participants undergo ERCP using either the Exalt Model D single-use duodenoscope or a standard reusable duodenoscope.
1 procedure visit (in-person)
Duration - Up to 7 days post-procedure
Participants are monitored for adverse events and outcomes up to 7 days after the ERCP procedure as part of standard care.
Approximately 1 follow-up visit
Trial Site Locations
Total: 1 location
1
Rush University Medical Center
Chicago, Illinois, United States, 60607
Actively Recruiting
Research Team
N
Neal A Mehta, MD
A
Amanda F Lin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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