NCT06855485Recruiting
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
Source: ClinicalTrials.gov · Last updated 3 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 23 Feb 2025
- Start date
- 25 Feb 2025
- Primary completion date
- 30 Aug 2025
- Lead sponsor
- Asan Medical Center
- NCT number
- NCT06855485
What you commit to
- Study type: Interventional
- Planned participants: 20
- From 25 Feb 2025 to the primary completion date, 30 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Uncontrolled coagulation disorders:
- Other bleeding disorders
- History of anaphylactic reaction to stent materials
Lab values
- INR \> 1.5
- Platelet count \< 50,000/mm³
Age
- Younger than 18 years old
Other
- Pseudocysts with the following characteristics:
- Immature pseudocyst
- Cystic neoplasm
- Pseudoaneurysm
- Multiple pseudocysts requiring drainage
- Ineligibility for EUS-guided drainage due to anatomical or technical reasons
- Pregnant or potentially pregnant women
- Current participation in another clinical trial that may affect study outcomes
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.