Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Pseudocyst | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HANAROSTEN® HOT Plumber™ with Z-EUSIT™ | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Intervention Group
- description
- Participants will undergo endoscopic ultrasound-guided drainage of pancreatic pseudocysts using the HANAROSTEN® HOT Plumber™ with Z-EUSIT™.
- interventionNames
- Device: HANAROSTEN® HOT Plumber™ with Z-EUSIT™
Primary outcomes (1)
- measure
- Clinical Success
- timeFrame
- Within 30 or 60 days after stent placement
- description
- Reduction of pancreatic pseudocyst size by at least 50% with improvement in associated symptoms.
Secondary outcomes (6)
- measure
- Technical Success - Stent Placement
- timeFrame
- During procedure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available