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

Study Overview
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Brief Summary
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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.

Detailed Description
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'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.

Official Title
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A Prospective, Multi-center, Single Arm, Non-inferiority, Open-label, Pivotal Study to Evaluate the Effectiveness and Safety of EUS -Guided Transluminal Drainage With 'Niti-S SPAXUS Stent' for the Treatment of Pancreatic Pseudocyst

Conditions
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Pancreatic Pseudocyst

Intervention / Treatment
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* Device: Niti-S SPAXUS Stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The investigational device (ID) 'Niti-S SPAXUS Stent' is used for drainage of cystic fluid by being connected to the pancreatic pseudocyst through human organs such as stomach or duodenum. It is composed with a stent made of nitinol and introducer system.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Niti-S SPAXUS Stent<br>Niti-S SPAXUS Stent (TaeWoong Medical Co., Ltd. Korea) | Device: Niti-S SPAXUS Stent<br>* Endoscopic Ultrasound-Guided Transluminal drainage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Clinical Success | Clinical success is defined as ≥50% decrease in pancreatic pseudocyst size measured on Computed Tomography (CT) | at stent removal (Day 30 or Day 60) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1 | 
| Number of Participants With Stent Lumen Patency | Stent lumen patency will be evaluated by endoscopy. | 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. | 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) | 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 | up to 90 days (at Day 20 post stent removal) | 
| Other Adverse Events | The severity and incidence of all other adverse events than those mentioned above occurred during the follow-up period were evaluated at Day 20 day after the stent removal. | up to 90 days (at Day 20 post stent removal) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic ultrasound guided transluminal drainage