Comparing single-use and reusable duodenoscopes for treating biliary and pancreatic disorders
Official title: Exalt Single-use Duodenoscope Vs Reusable Scope, a Randomized Controlled Trial
Run by Rush University Medical Center · NCT06895785 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Rush University Medical Center Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Status | Recruiting |
| Started | February 21, 2025 |
| Main results expected | February 2030 |
| Study ends | May 2030 |
| Registry record updated | March 26, 2025 |
| Trial ID | NCT06895785 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 with biliary or pancreatic duct disorders confirmed by clinical symptoms and imaging.
✕Probably not a fit
Patients with altered pancreaticobiliary anatomy, pregnancy, or prior history of ERCP may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have indicated that single-use endoscopes can reduce infection risks, suggesting a promising approach in this area.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Repeat gallbladder ultrasound in the ED to detect early acute cholecystitis
In adults with abdominal pain and an initially non-diagnostic gallbladder ultrasound in the emergency department, this study tests whether a second ultrasound can help confirm acute cholecystitis sooner.
-
Treatment of bile duct diseases using a mini-endoscopic system
This study is testing a new mini-endoscopic system to see if it can help people with bile duct diseases who can’t have regular endoscopic treatments.
-
Pharmacist-led blood pressure care delivered in Chicago neighborhoods
This program tests whether a mobile pharmacist-led team can help adults with uncontrolled high blood pressure on Chicago's West and South Sides lower their blood pressure when care is offered in trusted community settings.
-
Paracervical Block With Ketorolac and Lidocaine for Osmotic Dilator Placement
This study tests whether a ketorolac and lidocaine injection around the cervix improves pain control for people needing osmotic dilators before a second-trimester abortion.
-
PTSD treatment delivered by your primary care nurse
This will test whether nurses trained to deliver a short, four-session trauma therapy can help primary care patients who develop PTSD after a recent life-threatening heart or stroke event.
-
Holmium laser versus electrohydraulic lithotripsy for difficult bile duct and pancreatic duct stones
This will test whether a low-power holmium laser works and is as safe as electrohydraulic lithotripsy for adults with large or hard-to-remove bile duct or pancreatic duct stones.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.