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Exalt Single-use Duodenoscope Vs Reusable Scope, a Randomized Controlled Trial

Who can join

Ages 19 and older · All sexes

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

About the study

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.

What is being tested

• Exalt Model D (device)
• Reusable (device)

Sponsor: Rush University Medical Center · Participants: 100 · Started: Feb 21, 2025

Contact the study team

• Neal A Mehta, MD · Phone: 3129428651
• Amanda F Lin · Phone: 3125633907

Official record on ClinicalTrials.gov — NCT06895785

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.