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

Taewoong Medical

Status

Completed

Conditions

Pancreatic Pseudocyst

Treatments

Device: Niti-S SPAXUS Stent

Study type

Interventional

Funder types

Industry

Identifiers

NCT02730663

SPAXUS-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

19+ years old

Volunteers

No 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