Duodenoscope for Biliary Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new, single-use duodenoscope called the Exalt Model D, comparing it to the traditional reusable scope. The researchers aim to determine which scope is easier to use, has fewer side effects, and reduces infection risk during procedures for bile duct or pancreatic issues. Suitable candidates for this trial include individuals with symptoms of biliary or pancreatic duct disorders confirmed by specific imaging tests and who have not undergone certain previous procedures. As an unphased trial, participants can contribute to pioneering research that may enhance future medical procedures.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What prior data suggests that this duodenoscope is safe for biliary disease?
Research has shown that the Exalt Model D, a single-use duodenoscope, is generally safe for patients. In a study with 98 participants, researchers used this device for ERCP, a procedure that examines the bile and pancreatic ducts. The study found that this single-use scope worked successfully in 91.7% of the procedures, with only one instance where the scope did not stay in place properly.
Another study demonstrated a high success rate of 98.5% when the Exalt Model D was used with another single-use scope. No major safety issues were reported, suggesting that the Exalt Model D is well-tolerated and has a low risk of complications.12345Why are researchers excited about this trial?
Researchers are excited about the Exalt Model D duodenoscope because it offers a single-use design, which significantly reduces the risk of cross-contamination and infection associated with traditional reusable duodenoscopes. This is a big deal because standard reusable models require complex cleaning procedures that aren’t always foolproof. The Exalt Model D provides a fresh scope for each procedure, potentially improving patient safety and reducing the burden on healthcare facilities to maintain rigorous cleaning protocols.
What evidence suggests that this trial's duodenoscopes could be effective for biliary disease?
In this trial, participants will be assigned to one of two treatment arms: the Exalt Model D, a single-use scope, or a standard reusable duodenoscope for ERCP procedures. Research has shown that the Exalt Model D performs well for ERCP procedures, successfully completing the procedure in 97.2% of cases in one study. Another study found it to be a practical and cost-effective alternative to reusable scopes, particularly in reducing infection risks. Although a small number of users experienced difficulty with positioning, this issue also occurred with reusable scopes. Overall, the Exalt Model D is a reliable choice for procedures related to bile duct diseases.46789
Who Is on the Research Team?
Neal A Mehta, MD
Principal Investigator
Rush University Medical Center
Are You a Good Fit for This Trial?
This trial is for individuals with gallbladder disorders, pancreatic duct dysfunction, or biliary disease. Specific eligibility criteria are not provided, but typically participants would need to meet certain health conditions relevant to the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo ERCP using either the Exalt Model D single-use duodenoscope or the standard reusable duodenoscope
Follow-up
Participants are monitored for adverse events and infection rates post-ERCP
What Are the Treatments Tested in This Trial?
Interventions
- Exalt Model D
- Reusable
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rush University Medical Center
Lead Sponsor