Clinical Trial: An Early Safety and Efficacy Study of Ascites Management: Standard Paracentesis or Early Intervention With Pleurx Catheters in Patients With Malignant Ascites
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: An Early Safety and Efficacy Study of Ascites Management: Standard Paracentesis or Early Intervention With Pleurx Catheters in Patients With Malignant 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
Sponsor: Sidney Kimmel Comprehensive Cancer Center
Current Primary Outcome: Safety of Pleurx Catheter or Paracentesis [ Time Frame: 3 years ]
Primary Outcome: Safety of the Pleurx catheter procedure or paracentesis
Safety of the pleurx catheter procedure or paracentesis. Safety will be assessed by the degree of unacceptable toxicities, defined as life threatening complications related to the procedure. These include peritonitis, perforation, or death related to the procedure.
Original Primary Outcome: Safety of Pleurx Catheter or Paracentesis [ Time Frame: 3 years ]
Current Secondary Outcome:
Original Secondary Outcome: Overall complications, quality of life, overall survival, and symptom control [ Time Frame: 3 years ]
Information By: Sidney Kimmel Comprehensive Cancer Center
Dates:
Date Received: February 25, 2010
Date Started: February 2010
Date Completion:
Last Updated: October 6, 2015
Last Verified: October 2015
