Comparing single-use and reusable duodenoscopes for treating biliary and pancreatic disorders
Exalt Single-use Duodenoscope Vs Reusable Scope, a Randomized Controlled Trial
This study is testing whether a single-use duodenoscope is safer and more effective than a reusable one for treating patients with biliary and pancreatic disorders.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Rush University Medical Center Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06895785 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the Exalt Model disposable duodenoscope against a reusable duodenoscope in patients with biliary and pancreatic duct disorders. It focuses on assessing feasibility, ease of use, adverse events, crossover events, and infection rates associated with each type of duodenoscope. The study aims to address concerns regarding infection control and cross-contamination linked to reusable scopes, which have been associated with serious patient harm. By utilizing a single-use platform, the trial seeks to enhance patient safety and procedural effectiveness.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with biliary or pancreatic duct disorders confirmed by clinical symptoms and imaging.
Not a fit: Patients with altered pancreaticobiliary anatomy, pregnancy, or prior history of ERCP may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce infection rates and improve patient outcomes during endoscopic procedures.
How similar studies have performed: Other studies have indicated that single-use endoscopes can reduce infection risks, suggesting a promising approach in this area.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois
- Rush University Medical Center — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Neal A Mehta, MD — Rush University Medical Center
- Study coordinator: Neal A Mehta, MD
- Email: Neal_A_Mehta@rush.edu
- Phone: 3129428651
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.