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Comparing Fully Covered, Self Expanding Metal Stent (FCSEMS) and Plastic Stents for EUS- Guided Drainage of WON

NCT02718092 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-10-03

No results posted yet for this study

Summary

This is a multi-center, single-blinded, randomized trial comparing AXIOS FCSEMS (Fully Covered Self Expanding Metal Stent) and plastic stents for EUS (Endoscopic Ultrasound)-guided management of infected and/or symptomatic WON (Walled Off Necrosis).

Patients will be randomized to either FCSEMS or plastic stents for EUS-guided drainage of WON in a 1:1 manner. Following EUS-guided drainage patients in both groups will be assessed pre- procedure, pre -discharge, weeks 1, 6 and months 3, 6, 12 and 24 months. Information will also be collected from any subsequent hospital admissions related to their walled-off necrosis.

Conditions

  • Walled-off Necrosis

Interventions

DEVICE

Plastic Stent

Subjects who are randomized to this arm will receive a plastic stent

DEVICE

Axios Fully Covered Self Expanding Metal Stent

Subjects who are randomized to this arm will receive the Axios FCEMS

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Jeffrey Easler, MD · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-08-23
Completion
2017-08-23
FDA Device
Yes

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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 NCT02718092 on ClinicalTrials.gov