Efficacy and Safety of HANAROSTEN® HOT Plumber™ With Z-EUSIT™ for Pancreatic Pseudocyst Drainage (NCT06855485) | Clinical Trial Compass
RecruitingNot Applicable
Efficacy and Safety of HANAROSTEN® HOT Plumber™ With Z-EUSIT™ for Pancreatic Pseudocyst Drainage
South Korea20 participantsStarted 2025-02-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical Success
Timeframe: Within 30 or 60 days after stent placement