Trials / Completed
CompletedNCT02730663
A Study to Evaluate the Effectiveness and Safety of EUS-guided Transluminal Drainage With 'Niti-S SPAXUS Stent'
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Taewoong Medical Co., Ltd. · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Niti-S SPAXUS Stent | Endoscopic Ultrasound-Guided Transluminal drainage |
Timeline
- Start date
- 2016-03-21
- Primary completion
- 2017-06-14
- Completion
- 2017-06-14
- First posted
- 2016-04-06
- Last updated
- 2019-09-17
- Results posted
- 2019-07-01
Locations
6 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02730663. Inclusion in this directory is not an endorsement.