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

Recruiting now · Not applicable

Conditions studied: Pancreatic Pseudocyst

In brief

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.

Key facts

Study ID

NCT06855485

Run by

Asan Medical Center

People needed

20

Starts

2025-02-25

Expected to finish

2025-12-30

Last updated by the study team

2025-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must be 18 years or older
• Diagnosed with pancreatic or peripancreatic pseudocyst or walled-off necrosis (with less than 30% solid components)
• Eligible for endoscopic ultrasound-guided drainage
• Able to provide informed consent and comply with study procedures

You may not qualify if…

• Younger than 18 years old
• Pseudocysts with the following characteristics:
• Immature pseudocyst
• Cystic neoplasm
• Pseudoaneurysm
• Multiple pseudocysts requiring drainage
• Uncontrolled coagulation disorders:
• INR > 1.5
• Platelet count < 50,000/mm³
• Other bleeding disorders
• Ineligibility for EUS-guided drainage due to anatomical or technical reasons
• History of anaphylactic reaction to stent materials
• Pregnant or potentially pregnant women
• Current participation in another clinical trial that may affect study outcomes

Where it is running

• Asan Medical Center — Seoul, Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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