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Comparison of FCSEMS and Plastic Stents

NCT02685865 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-02-11

No results posted yet for this study

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.

Conditions

  • Infected Pancreatic Necrosis
  • Acute Pancreatic Fluid Collection
  • Pancreatic and Peripancreatic Necrosis
  • Pancreatic Collection
  • Symptomatic Pancreatic Necrosis

Interventions

DEVICE

FCSEM Stent

Hot Axios Fully covered self-expandable metal stent - Boston Scientific

DEVICE

Plastic Stent

7 French 4 cm double pigtail plastic stent - Cook 7 French 4 cm double pigtail plastic stent - Boston Scientific

Sponsors & Collaborators

  • AdventHealth

    lead OTHER

Principal Investigators

  • Shyam Varadarajulu, MD · Florida Hospital Orlando

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-12
Primary Completion
2018-07-10
Completion
2018-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02685865 on ClinicalTrials.gov