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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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 Tre

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 Summary: '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.
Sponsor: Taewoong Medical Co., Ltd.

Current Primary Outcome: Clinical success [ Time Frame: at stent removal (Day 30 or 60) ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Technical success [ Time Frame: 1day ]
    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.
  • Stent lumen patency [ Time Frame: up to 60 days (at stent removal, Day 30 or 60) ]
    Stent lumen patency will be evaluated by endoscopy.
  • Stent removal success [ Time Frame: up to 60 days (at stent removal, Day 30 or 60) ]
    Stent removal success is defined as successful removal of the Niti-S SPAXUS stent using a standard endoscopic forceps or snare.
  • Procedure time [ Time Frame: 1 day ]
    Procedure time is measured as time from insertion until removal of endoscope.
  • Procedural / Device related serious adverse events [ Time Frame: up to 90 days (at Day 20 post stent removal) ]
  • Other adverse events [ Time Frame: up to 90 days (at Day 20 post stent removal) ]


Original Secondary Outcome: Same as current

Information By: Taewoong Medical Co., Ltd.

Dates:
Date Received: March 28, 2016
Date Started: March 21, 2016
Date Completion: August 2017
Last Updated: May 21, 2017
Last Verified: May 2017