Clinical trial NCT02730663: A Study to Evaluate the Effectiveness and Safety of EUS-guided Transluminal Drainage With 'Niti-S SPAXUS Stent'
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Pseudocyst
Keywords: Endoscopic ultrasound guided transluminal drainage
Lead sponsor: Taewoong Medical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-04-06
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: '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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Clinical Success
timeFrame: at stent removal (Day 30 or Day 60)
Secondary outcomes:
measure: Number of Participants With Technical Success
timeFrame: Day 1
measure: Number of Participants With Stent Lumen Patency
timeFrame: up to 60 days (at stent removal, Day 30 or 60)
measure: Number of Participants With Stent Removal Success
timeFrame: up to 60 days (at stent removal, Day 30 or 60)
measure: Procedure Time
timeFrame: 1 day
measure: Number of Participants With Procedural/Device Related Serious Adverse Events
timeFrame: up to 90 days (at Day 20 post stent removal)
measure: Other Adverse Events
timeFrame: up to 90 days (at Day 20 post stent removal)
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
state: Gyeonggi-do
city: Hwaseong-si
country: Korea, Republic of
facility: Hallym University Dongtan Sacred Heart Hospital
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Medical Center
city: Jeonju
country: Korea, Republic of
facility: Chonbook National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Soon Chun Hyang University
name: Jong Ho Moon, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Sang Soo Lee, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Jong Kyun Lee, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonbuk National University Hospital
name: Seung-Ok Lee, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyungpook National University Medical Center
name: Chang Min Cho, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hallym University Dongtan Sacred Heart Hospital
name: Se Woo Park, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Song TJ, Lee SS, Moon JH, Choi HJ, Cho CM, Lee KH, Park SW, Kim SH, Lee SO, Lee YN, Lee JK. Efficacy of a novel lumen-apposing metal stent for the treatment of symptomatic pancreatic pseudocysts (with video). Gastrointest Endosc. 2019 Sep;90(3):507-513. doi: 10.1016/j.gie.2019.05.033. Epub 2019 May 30.