Clinical Trial: A Clinical Study Evaluating the Safety and Effectiveness of a New Pleural Catheter for the Medical Management of Symptomatic, Recurrent, Malignant Pleural Effusions Compared to Approved Pleural Catheter.
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title:
Brief Summary: The purpose of this study is to determine whether a new catheter is safe and effective in treating malignant pleural effusions compared to approve catheter.
Detailed Summary:
Sponsor: CareFusion
Current Primary Outcome: The proportion of subjects achieving pleurodesis without recurrence [ Time Frame: 30 days post catheter insertion ]
Original Primary Outcome:
Current Secondary Outcome:
- Time to confirmed pleurodesis [ Time Frame: 30 days post insertion ]
- Time to recurrence [ Time Frame: 90 days post insertion ]
Original Secondary Outcome:
Information By: CareFusion
Dates:
Date Received: December 18, 2015
Date Started: May 2016
Date Completion: February 2018
Last Updated: August 4, 2016
Last Verified: August 2016
