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

Description

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.

Conditions

Biliary Diseases, Pancreatic Duct Disorder

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Biliary Diseases
Intervention / Treatment

-

Contacts and Locations

Chicago

Rush University Medical Center, Chicago, Illinois, United States, 60607

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * Patients with altered pancreaticobiliary anatomy
  • * Pregnancy
  • * Patients with percutaneous transhepatic biliary drainage
  • * Prior history of ERCP
  • * Inability to provide informed consent

Ages Eligible for Study

19 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Rush University Medical Center,

Neal A Mehta, MD, PRINCIPAL_INVESTIGATOR, Rush University Medical Center

Study Record Dates

2030-05