NCT06855485 Efficacy and Safety of HANAROSTEN® HOT Plumber™ With Z-EUSIT™ for Pancreatic Pseudocyst Drainage
| NCT ID | NCT06855485 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Asan Medical Center |
| Condition | Pancreatic Pseudocyst |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-02-25 |
| Primary Completion | 2025-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-02-25 with a primary completion date of 2025-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Dongwook Oh, MD, PhD
STUDY DIRECTOR
Asan Medical Center
Frequently Asked Questions
Who can join the NCT06855485 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pancreatic Pseudocyst. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06855485 currently recruiting?
Yes, NCT06855485 is actively recruiting participants. Contact the research team at medi01@naver.com for enrollment information.
Where is the NCT06855485 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT06855485 clinical trial?
NCT06855485 is sponsored by Asan Medical Center. The principal investigator is Dongwook Oh, MD, PhD at Asan Medical Center. The trial plans to enroll 20 participants.