Exalt Single-use Duodenoscope Vs Reusable Scope, a Randomized Controlled Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorRush University Medical Center
About this trial
This randomized controlled trial (RCT) is designed to evaluate the new generation Exalt Model disposable duodenoscope compared to the reusable scope in terms of feasibility, ease of use, adverse events, number of crossover events, and infection rates.
Eligibility criteria
Qualifiers
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
Disqualifiers
Patients with altered pancreaticobiliary anatomy
Pregnancy
Patients with percutaneous transhepatic biliary drainage
Prior history of ERCP
Trial design
Treatments tested in this trial
- Exalt Model D
- Reusable
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov