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Efficacy and Safety of HANAROSTEN® HOT Plumber™ With Z-EUSIT™ for Pancreatic Pseudocyst Drainage

NCT06855485 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-03-03

No results posted yet for this study

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.

Conditions

  • Pancreatic Pseudocyst

Interventions

DEVICE

HANAROSTEN® HOT Plumber™ with Z-EUSIT™

An electrocautery-enhanced lumen-apposing metal stent designed for the drainage of pancreatic pseudocysts. The stent is delivered using a system that allows for single-step deployment without the need for guidewire exchanges or tract dilation.

Sponsors & Collaborators

  • M.I.Tech Co., Ltd.

    collaborator UNKNOWN

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Dongwook Oh, MD, PhD · Asan Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-25
Primary Completion
2025-08-30
Completion
2025-12-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06855485 on ClinicalTrials.gov