At a glance
ClinicalIndex Comparison RecordN/ACompleted· 60 enrolled
Drug / intervention
FCSEM Stent +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Trial Comparing Fully Covered, Self-Expanding Metal Stent and Plastic Stents for Endoscopic Ultrasound-guided Drainage of Walled-off Necrosis
In Brief
A clinical study evaluating FCSEM Stent and Plastic Stent for Infected Pancreatic Necrosis and 4 related conditions. Completed, enrolled 60 participants across 2 sites.
Detailed Summary
The research design is a randomized prospective clinical trial comparing Endoscopic ultrasound (EUS) guided drainage of WON using FCSEMS and plastic stents. The trial will be conducted at the Florida Hospital Center for Interventional Endoscopy, Orlando, Florida.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfected Pancreatic Necrosis, Acute Pancreatic Fluid Collection, Pancreatic and Peripancreatic Necrosis, Pancreatic Collection, Symptomatic Pancreatic Necrosis
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartFeb 2016
First PostedFeb 2016
Primary CompletionJul 2018
Study CompletionAug 2018
TodayJul 2026
First PostedFeb 19, 2016
Enrollment StartFeb 12, 2016
Primary CompletionJul 10, 2018
Study CompletionAug 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 10.4 years ago
Interventions
FCSEM Stentdevice
Hot Axios Fully covered self-expandable metal stent - Boston Scientific
Plastic Stentdevice
7 French 4 cm double pigtail plastic stent - Cook 7 French 4 cm double pigtail plastic stent - Boston Scientific