RecruitingNot ApplicableNCT06855485

Efficacy and Safety of HANAROSTEN® HOT Plumber™ With Z-EUSIT™ for Pancreatic Pseudocyst Drainage

A Prospective Single-Center Observational Study on the Evaluation of Efficacy and Safety of HANAROSTEN® HOT Plumber™ With Z-EUSIT™ for Pancreatic Pseudocysts Drainage


Sponsor

Asan Medical Center

Enrollment

20 participants

Start Date

Feb 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this prospective, single-center observational study is to evaluate the safety and effectiveness of the HANAROSTEN® HOT Plumber™ with Z-EUSIT™ for draining pancreatic pseudocysts. The main questions the study aims to answer are: * Does the device reduce the size of pancreatic pseudocysts by at least 50% and improve associated symptoms within 30 to 60 days? * Can the stent be successfully placed, retained, and removed without complications? Participants will: * Undergo endoscopic ultrasound-guided transgastric or transduodenal drainage of pancreatic pseudocysts using the HANAROSTEN® HOT Plumber™ with Z-EUSIT™. * Be monitored for adverse events such as bleeding, infection, stent migration, or tissue injury. * Return for follow-up visits within 30 or 60 days for stent removal and evaluation of clinical success. The study will: * Enroll 20 adults aged 18 years or older who meet the inclusion criteria. * Conduct follow-up assessments until one month after stent removal.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests the safety and effectiveness of a specialized endoscopic stent system for draining fluid-filled sacs (pseudocysts) that sometimes develop near the pancreas, usually after pancreatitis. **You may be eligible if:** - You are 18 years or older - You have been diagnosed with a pancreatic pseudocyst or a walled-off area of tissue fluid near the pancreas - You are a candidate for drainage using an endoscope (a scope passed through the mouth into the stomach) **You may NOT be eligible if:** - You are under 18 years old - The cyst is immature, is a cystic tumor, or has a blood vessel abnormality inside it - You need drainage of multiple pseudocysts at the same time - You have an uncontrolled blood clotting disorder (INR above 1.5 or very low platelets) - You have a body structure that makes the endoscopic procedure technically impossible - You have had an allergic reaction to the type of stent material used - You are pregnant - You are currently in another clinical trial that could affect results Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEHANAROSTEN® HOT Plumber™ with Z-EUSIT™

An electrocautery-enhanced lumen-apposing metal stent designed for the drainage of pancreatic pseudocysts. The stent is delivered using a system that allows for single-step deployment without the need for guidewire exchanges or tract dilation.


Locations(1)

Asan Medical Center

Seoul, Seoul, South Korea

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06855485


Related Trials