Evaluating a new device for draining pancreatic pseudocysts
Official title: A Prospective Single-Center Observational Study on the Evaluation of Efficacy and Safety of HANAROSTEN® HOT Plumber™ With Z-EUSIT™ for Pancreatic Pseudocysts Drainage
Run by Asan Medical Center · NCT06855485 · Data updated 2026-11-12
This study is testing a new device to see if it safely and effectively helps adults with pancreatic pseudocysts get better by draining the fluid and reducing their symptoms.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Asan Medical Center Academic / other |
| Locations | 1 site (Seoul, Seoul) |
| Status | Recruiting |
| Started | February 25, 2025 |
| Main results expected | August 30, 2025 |
| Study ends | December 30, 2025 |
| Registry record updated | March 3, 2025 |
| Trial ID | NCT06855485 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 years or older diagnosed with pancreatic or peripancreatic pseudocysts eligible for endoscopic ultrasound-guided drainage.
✕Probably not a fit
Patients with certain types of pseudocysts, uncontrolled coagulation disorders, or those currently participating in other clinical trials may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, single-center observational study aims to assess the safety and effectiveness of the HANAROSTEN® HOT Plumber™ with Z-EUSIT™ for draining pancreatic pseudocysts. Participants will undergo endoscopic ultrasound-guided drainage and will be monitored for complications and clinical success, defined as a reduction in pseudocyst size by at least 50% and symptom improvement within 30 to 60 days. The study will enroll 20 adults who meet specific inclusion criteria and will follow up with them until one month after stent removal.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive and effective treatment option for patients with pancreatic pseudocysts.
How similar studies have gone: Other studies have shown success with similar endoscopic drainage techniques, but the specific device being tested in this study is novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Asan Medical Center
Seoul, Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Tae Jun Song, MD, PhD
- Email: medi01@naver.com
- Phone: 82-2-3010-3914
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.