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The purpose of this study is to assess in a controlled prospective setting, the safety of the use of Pleurx catheters and standard therapeutic paracentesis in patients with malignant ascites.
Study Design: Single institution, open-label, randomized study
Study Device: Pleurx Catheter
Treatment Plan: Cohort A: 15 patients treated with standard therapy (therapeutic paracentesis +/- diuretics)
Cohort B: 15 patients treated with peritoneal pleurx catheter
Duration of Participation: Patients will be followed for one year, or until death, whichever comes first.
Primary Outcome: Safety of the pleurx catheter procedure or paracentesis
Secondary outcomes: Overall complications, quality of life, overall survival, and symptom control
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
paracentesis, pleurx catheter
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sidney Kimmel Comprehensive Cancer Center
Published on BioPortfolio: 2014-08-27T03:15:36-0400
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