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Efficacy and Safety of HANAROSTEN® HOT Plumber™ With Z-EUSIT™ for Pancreatic Pseudocyst Drainage
Sponsor: Asan Medical Center
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.
Official title: A Prospective Single-Center Observational Study on the Evaluation of Efficacy and Safety of HANAROSTEN® HOT Plumber™ With Z-EUSIT™ for Pancreatic Pseudocysts Drainage
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-02-25
Completion Date
2025-12-30
Last Updated
2025-03-03
Healthy Volunteers
No
Conditions
Interventions
HANAROSTEN® 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