N/A N=36 Treatment

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

Pancreatic Pseudocyst

Bottom Line

View on ClinicalTrials.gov: NCT02730663 ↗

Enrolled (actual)

Serious AEs

40.0%

Results posted

Jul 2019

Primary outcome: Primary: Number of Participants With Clinical Success — 33 participants — p=0.05

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Niti-S SPAXUS Stent (Device)
Age: Adult, Older Adult · 19+ yrs
Sex: All
Sponsor: Taewoong Medical Co., Ltd.
Primary completion: Jun 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Clinical Success	33	0.05
SECONDARY Number of Participants With Technical Success	33	—
SECONDARY Number of Participants With Stent Lumen Patency	34	—
SECONDARY Number of Participants With Stent Removal Success	34	—
SECONDARY Procedure Time	1074.88; 618.12	—
SECONDARY Number of Participants With Procedural/Device Related Serious Adverse Events	14	—
SECONDARY Other Adverse Events	154	—

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.

Eligibility Criteria

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02730663). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.