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

ConditionPancreatic Pseudocyst
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAsan Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Younger than 18 years old

Immature pseudocyst

Cystic neoplasm

Pseudoaneurysm

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Single Intervention GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Clinical Success

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

Time frame
Within 30 or 60 days after stent placement

Secondary outcomes

1

Technical Success - Stent Placement

Successful deployment of the stent at the intended site.

Time frame
During procedure
2

Technical Success - Stent Removal

Successful removal of the stent after pseudocyst resolution, confirmed by endoscopic confirmation of complete stent removal without residual fragments.

Time frame
Within 30 or 60 days after placement
3

Stent Retention

Retention of the stent in the intended location without migration until removal.

Time frame
Within 30 or 60 days after placement
4

Lumen Patency

Maintenance of an open lumen allowing fluid drainage until stent removal.

Time frame
Within 30 or 60 days after placement

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Asan Medical Center

Lead sponsor

M.I.Tech Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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