Actively Recruiting
Efficacy and Safety of HANAROSTEN® HOT Plumber™ With Z-EUSIT™ for Pancreatic Pseudocyst Drainage
Led by Asan Medical Center · Updated on 2025-03-03
20
Participants Needed
1
Research Sites
44 weeks
Total Duration
On this page
Sponsors
A
Asan Medical Center
Lead Sponsor
M
M.I.Tech Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of HANAROSTEN® HOT Plumber™ With Z-EUSIT™ for Pancreatic Pseudocyst Drainage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Younger than 18 years old
- Immature pseudocyst
- Cystic neoplasm
- Pseudoaneurysm
- Multiple pseudocysts requiring drainage
- Uncontrolled coagulation disorders including INR > 1.5 or platelet count < 50,000/mm9
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Asan Medical Center
Seoul, Seoul, South Korea, 05505
Actively Recruiting
Research Team
T
Tae Jun Song, MD, PhD
CONTACT
Y
Yoonchan Lee, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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