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

Primary Purpose

Pancreatic Pseudocyst

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Niti-S SPAXUS Stent
Sponsored by
Taewoong Medical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Pseudocyst focused on measuring Endoscopic ultrasound guided transluminal drainage

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Soon Chun Hyang University Hospital Bucheon
  • Hallym University Dongtan Sacred Heart Hospital
  • Kyungpook National University Medical Center
  • Chonbook National University Hospital
  • Asan Medical Center
  • Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Niti-S SPAXUS Stent

Arm Description

Niti-S SPAXUS Stent (TaeWoong Medical Co., Ltd. Korea)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Number of Participants With Stent Lumen Patency
Stent lumen patency will be evaluated by endoscopy.
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.
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)
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
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.

Full Information

First Posted
March 28, 2016
Last Updated
September 9, 2019
Sponsor
Taewoong Medical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02730663
Brief Title
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

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 21, 2016 (Actual)
Primary Completion Date
June 14, 2017 (Actual)
Study Completion Date
June 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taewoong Medical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Pseudocyst
Keywords
Endoscopic ultrasound guided transluminal drainage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Niti-S SPAXUS Stent
Arm Type
Experimental
Arm Description
Niti-S SPAXUS Stent (TaeWoong Medical Co., Ltd. Korea)
Intervention Type
Device
Intervention Name(s)
Niti-S SPAXUS Stent
Intervention Description
Endoscopic Ultrasound-Guided Transluminal drainage
Primary Outcome Measure Information:
Title
Number of Participants With Clinical Success
Description
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 Outcome Measure Information:
Title
Number of Participants With Technical Success
Description
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
Title
Number of Participants With Stent Lumen Patency
Description
Stent lumen patency will be evaluated by endoscopy.
Time Frame
up to 60 days (at stent removal, Day 30 or 60)
Title
Number of Participants With Stent Removal Success
Description
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)
Title
Procedure Time
Description
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
Title
Number of Participants With Procedural/Device Related Serious Adverse Events
Description
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)
Title
Other Adverse Events
Description
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.
Time Frame
up to 90 days (at Day 20 post stent removal)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong Ho Moon, PhD, MD
Organizational Affiliation
Soon Chun Hyang University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sang Soo Lee, PhD, MD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jong Kyun Lee, PhD, MD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Seung-Ok Lee, PhD, MD
Organizational Affiliation
Chonbuk National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chang Min Cho, PhD, MD
Organizational Affiliation
Kyungpook National University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Se Woo Park, PhD, MD
Organizational Affiliation
Hallym University Dongtan Sacred Heart Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soon Chun Hyang University Hospital Bucheon
City
Bucheon
State/Province
Gyeonggi-do
ZIP/Postal Code
14584
Country
Korea, Republic of
Facility Name
Hallym University Dongtan Sacred Heart Hospital
City
Hwaseong-si
State/Province
Gyeonggi-do
ZIP/Postal Code
18450
Country
Korea, Republic of
Facility Name
Kyungpook National University Medical Center
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Chonbook National University Hospital
City
Jeonju
ZIP/Postal Code
54907
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Oct, 2016
Citations:
PubMed Identifier
31152738
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.
Results Reference
derived

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

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