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

Inclusion Criteria4

  • 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 Criteria14

  • 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

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

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NCT06855485


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