RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-02-21
Study Completion:2030-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06895785

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.

Ages Eligible for Study:19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Native papilla
  1. * Patients with altered pancreaticobiliary anatomy
  2. * Pregnancy
  3. * Patients with percutaneous transhepatic biliary drainage
  4. * Prior history of ERCP
  5. * Inability to provide informed consent

Contacts and Locations

Study Contact

Neal A Mehta, MD
CONTACT
3129428651
Neal_A_Mehta@rush.edu
Amanda F Lin
CONTACT
3125633907
amanda_f_lin@rush.edu

Principal Investigator

Neal A Mehta, MD
PRINCIPAL_INVESTIGATOR
Rush University Medical Center

Study Locations (Sites)

Rush University Medical Center
Chicago, Illinois, 60607
United States

Collaborators and Investigators

Sponsor: Rush University Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-21
Study Completion Date2030-05

Study Record Updates

Study Start Date2025-02-21
Study Completion Date2030-05

Terms related to this study

Keywords Provided by Researchers

  • endoscopic retrograde cholangiopancreatography (ERCP)
  • duodenoscope
  • single-use
  • reusable
  • biliary disorder
  • pancreatic duct disorder

Additional Relevant MeSH Terms

  • Biliary Diseases
  • Pancreatic Duct Disorder