RecruitingNot ApplicableNCT06895785
Exalt Single-use Duodenoscope Vs Reusable Scope, a Randomized Controlled Trial
Sponsor
Rush University Medical Center
Enrollment
100 participants
Start Date
Feb 21, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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
Min Age: 19 Years
Inclusion Criteria2
- 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 Criteria5
- Patients with altered pancreaticobiliary anatomy
- Pregnancy
- Patients with percutaneous transhepatic biliary drainage
- Prior history of ERCP
- Inability to provide informed consent
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Interventions
DEVICEExalt Model D
Exalt Model D single-use duodenoscope will be used in ERCP
DEVICEReusable
Standard reusable duodenoscope will be used in ERCP
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06895785