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

NCT06855485 | Recruiting DMC

• 1 other identifier: ZEUS-PPD-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Pseudocyst

Keywords

Pancreatic Pseudocyst; Endosonography; Drainage; Stents

Outcome Measures

Primary Outcomes (1)

• Clinical Success

  Reduction of pancreatic pseudocyst size by at least 50% with improvement in associated symptoms.

  Within 30 or 60 days after stent placement

Secondary Outcomes (6)

• Technical Success - Stent Placement

  During procedure

• Technical Success - Stent Removal

  Within 30 or 60 days after placement

• Stent Retention

  Within 30 or 60 days after placement

• Lumen Patency

  Within 30 or 60 days after placement

• Procedure Duration

  During procedure

Study Arms (1)

Single Intervention Group

EXPERIMENTAL

Participants will undergo endoscopic ultrasound-guided drainage of pancreatic pseudocysts using the HANAROSTEN® HOT Plumber™ with Z-EUSIT™.

Device: HANAROSTEN® HOT Plumber™ with Z-EUSIT™

Interventions

HANAROSTEN® HOT Plumber™ with Z-EUSIT™ DEVICE

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.

Single Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead
• M.I.Tech Co., Ltd.: collaborator

Study Sites (1)

Asan Medical Center

Seoul, Seoul, 05505, South Korea

RECRUITING

MeSH Terms

Conditions

Pancreatic Pseudocyst

Condition Hierarchy (Ancestors)

Pancreatic Cyst; Cysts; Neoplasms; Pancreatic Diseases; Digestive System Diseases

Study Officials

• Dongwook Oh, MD, PhD

  Asan Medical Center

  STUDY DIRECTOR

Central Study Contacts

Tae Jun Song, MD, PhD

CONTACT

82-2-3010-3914; medi01@naver.com

Yoonchan Lee, MD

CONTACT

82-2-3010-1397; ycrlee@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The design is non-randomized, with no control or comparison group. The study aims to assess both clinical and technical success, as well as device-related safety outcomes.

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: March 3, 2025
• Study Start: February 25, 2025
• Primary Completion: August 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)