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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form and comply with study procedures Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Treatments Being Tested

DEVICE

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