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Impact of Aggressive Versus Standard Drainage Regimen Using a Long Term Indwelling Pleural Catheter

NCT00978939 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2013-12-30

No results posted yet for this study

Summary

Purpose and Objective: The purpose of this study is to determine if the rate of spontaneous pleurodesis using the Pleurx® catheter could be increased by simply increasing the frequency of pleural drainage and, if so, whether catheter-related complications can be minimized and spare patients the need for long term management of the Pleurx® catheter.

Conditions

  • Pleural Effusion, Malignant

Interventions

OTHER

Standard Drainage Instructions

Patients will receive specific instructions to drain up to 1 liter of pleural fluid every other day

OTHER

Aggressive Drainage Instructions

Patients will receive specific instructions to drain up to 1 liter of pleural fluid daily

Sponsors & Collaborators

Principal Investigators

  • Momen Wahidi, MD, MBA · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2013-03-31
Completion
2013-10-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00978939 on ClinicalTrials.gov