Recruiting NA Pancreatic Pseudocyst

Tests treatment safety and results for Pancreatic Pseudocyst

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

ClinicalTrials.gov ID: NCT06855485

What this study is testing

What it's testing
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?

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join 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 likely can't join if

  • Younger than 18 years old
  • Pseudocysts with the following characteristics:
  • Immature pseudocyst
  • Cystic neoplasm
  • Pseudoaneurysm
  • Multiple pseudocysts requiring drainage
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Seoul, Seoul, South Korea

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Seoul, Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.