NCT06895785 · Rush University Medical Center
Exalt Single-use Duodenoscope Vs Reusable Scope, a Randomized Controlled Trial
What this study is about
This randomly assigned 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, side effects, number of crossover events, and infection rates.
View original scientific 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.
Interventions
DEVICE
Exalt Model D
Exalt Model D single-use duodenoscope will be used in ERCP
DEVICE
Reusable
Standard reusable duodenoscope will be used in ERCP
Primary outcome measures
Number of attempts required to achieve successful cannulation of the desired duct
Time frame: From the time of the ERCP to 7 days post-ERCP per standard of care
Measure and compare the total number of attempts required to achieve successful cannulation of the desired duct.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Patients with percutaneous transhepatic biliary drainage
- Prior history of ERCP
- Inability to provide informed consent
Where
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 26, 2025 · Source of record for eligibility and locations