NCT01077063

An Early Safety and Efficacy Study of Ascites Management: Standard Paracentesis or Early Intervention With Pleurx Catheters in Patients With Malignant Ascites

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Malignant Ascites

Interventions

Type	Name	Description
PROCEDURE	paracentesis	surgical drainage of malignant ascites
DEVICE	Pleurx catheter	take home catheter drainage system that the subject uses himself/herself as needed.

Timeline

• Start date: 2010-02-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2010-02-26
• Last updated: 2015-10-29
• Results posted: 2014-09-22

Locations

1 site across 1 country: United States