A Study to Evaluate the Effectiveness and Safety of EUS-guided Transluminal Drainage With 'Niti-S SPAXUS Stent'

Taewoong Medical Co., Ltd.36 enrolled

Overview

The purpose of this study is to evaluate the safety and effectiveness of endoscopic ultrasound (EUS)-guided transluminal drainage with 'Niti-S SPAXUS Stent' for the treatment of pancreatic pseudocyst.

'Niti-S SPAXUS Stent' is a newly designed lumen-apposing fully covered self-expandable metal stent. It is indicated for use in patients with pancreatic pseudocyst. Consecutive subject data should be collected at discharge, stent removal (day 30 or 60), and day 20 post Niti-S SPAXUS stent removal.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Pseudocyst

Interventions

Niti-S SPAXUS StentDEVICE

Endoscopic Ultrasound-Guided Transluminal drainage

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pancreatic pseudocyst ≥6cm in size, with ≥70% fluid content that is eligible for transluminal drainage * Patient willing to provide written informed consent and comply with follow-up requirements Exclusion Criteria: * Ineligible for endoscopic intervention * Pancreatic pseudocyst with severe internal septation * Platelet count \< 60,000 cells/mm3 or international normalized ratio (INR) \>1.5 * Hemodynamic instability (e.g. shock) * Active infectious disease (e.g. endocarditis, meningitis) * Participating in any other investigational drug or device clinical trial within past 3 months * Female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant

Locations (6)

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, Gyeonggi-do, South Korea

Hallym University Dongtan Sacred Heart Hospital

Hwaseong-si, Gyeonggi-do, South Korea

Kyungpook National University Medical Center

Daegu, South Korea

Chonbook National University Hospital

Jeonju, South Korea

Outcomes

Primary Outcomes

Number of Participants With Clinical Success

Clinical success is defined as ≥50% decrease in pancreatic pseudocyst size measured on Computed Tomography (CT)

Time frame: at stent removal (Day 30 or Day 60)

Secondary Outcomes

Number of Participants With Technical Success

Technical success is defined as successful placement of the Niti-S SPAXUS stent across the gastric(or duodenal) wall to the pseudocyst with visualization of the pseudocyst fluid drainage through the stent by endoscopy.

Time frame: Day 1

Number of Participants With Stent Lumen Patency

Stent lumen patency will be evaluated by endoscopy.

Time frame: up to 60 days (at stent removal, Day 30 or 60)

Number of Participants With Stent Removal Success

Stent removal success is defined as successful removal of the Niti-S SPAXUS stent using a standard endoscopic forceps or snare.

Time frame: up to 60 days (at stent removal, Day 30 or 60)

Procedure Time

Procedure time is measured as time from insertion until removal of endoscope. Procedure time 1: The time from the moment that the endoscope is inserted into the oral cavity to the time point at which the endoscope is removed. (sec) Procedure time 2: The time from the puncture time to the point at which the ultrasound endoscope was removed. (sec)

Time frame: 1 day

Number of Participants With Procedural/Device Related Serious Adverse Events

The incidence of serious adverse events related to the procedure or the Niti-S SPAXUSTM stent is assessed at Day 20 after the stent removal

Time frame: up to 90 days (at Day 20 post stent removal)

Data from ClinicalTrials.gov

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