Clinical trialNACompleted
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
- Outcome
- Outcome unknown
- Phase
- NA
- Status
- Completed
- Study type
- Interventional
- Start
- 21 March 2016
- Expected end
- 14 June 2017
- Enrollment
- 36 participants
- Sites
- 6
- Primary outcomes
- Number of Participants With Clinical Success
- Sponsor
- Industry
- Results posted
- 2019-07-01
- Last update
- 17 September 2019
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Brief summary public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
'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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Number of Participants With Clinical Success [at stent removal (Day 30 or Day 60)]. Number, participants. Niti-S SPAXUS Stent (n=34): 33. Analysis, Niti-S SPAXUS Stent: Reference value -0.07; p=0.05; t-test, 2 sided; non inferiority.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With Technical Success [Day 1]. Count Of Participants, Participants. Niti-S SPAXUS Stent (n=34): 33.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With Stent Lumen Patency [up to 60 days (at stent removal, Day 30 or 60)]. Count Of Participants, Participants. Niti-S SPAXUS Stent (n=34): 34.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With Stent Removal Success [up to 60 days (at stent removal, Day 30 or 60)]. Count Of Participants, Participants. Niti-S SPAXUS Stent (n=34): 34.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Procedure Time [1 day]. Mean, sec (Standard Deviation). Procedure time 1: Niti-S SPAXUS Stent (n=34): 1074.88 (618.30). Procedure time 2: Niti-S SPAXUS Stent (n=34): 618.12 (341.63).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Number of Participants With Procedural/Device Related Serious Adverse Events [up to 90 days (at Day 20 post stent removal)]. Number, participants. Niti-S SPAXUS Stent (n=35): 14.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Other Adverse Events [up to 90 days (at Day 20 post stent removal)]. Number, case. Niti-S SPAXUS Stent (n=35): 154.