A Study to Evaluate the Effectiveness and Safety of EUS-guided Transluminal Drainage With 'Niti-S… (NCT02730663) | Clinical Trial Compass
CompletedNot Applicable
A Study to Evaluate the Effectiveness and Safety of EUS-guided Transluminal Drainage With 'Niti-S SPAXUS Stent'
South Korea36 participantsStarted 2016-03-21
Plain-language 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.
Who can participate
Age range19 Years
SexALL
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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