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

Pancreatic Pseudocyst Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02730663
• Other study ID #: SPAXUS-001
• Status: Completed
• Phase: N/A
• Start date: March 21, 2016
• Est. completion date: June 14, 2017

Study information

• Verified date: April 2019
• Source: Taewoong Medical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 14, 2017
• Est. primary completion date: June 14, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Pseudocyst

Intervention

Device:
• Niti-S SPAXUS Stent
Endoscopic Ultrasound-Guided Transluminal drainage

Locations

Country	Name	City	State
Korea, Republic of	Soon Chun Hyang University Hospital Bucheon	Bucheon	Gyeonggi-do
Korea, Republic of	Kyungpook National University Medical Center	Daegu
Korea, Republic of	Hallym University Dongtan Sacred Heart Hospital	Hwaseong-si	Gyeonggi-do
Korea, Republic of	Chonbook National University Hospital	Jeonju
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Taewoong Medical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)