Trials / Completed
CompletedNCT02649894
Safety and Effectiveness of a New Pleural Catheter for Symptomatic, Recurrent, MPEs Versus Approved Pleural Catheter
Pivotal Multi Center, Randomized, Controlled, Single-Blinded Study Comparing the Silver Nitrate Coated Indwelling Pleural Catheter to the Uncoated PleurX Catheter for the Management of Symptomatic, Recurrent, Malignant Pleural Effusions
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 119 (actual)
- Sponsor
- C. R. Bard · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter | |
| DEVICE | Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC) |
Timeline
- Start date
- 2016-05-01
- Primary completion
- 2018-04-18
- Completion
- 2018-04-18
- First posted
- 2016-01-08
- Last updated
- 2025-12-11
- Results posted
- 2020-08-13
Locations
19 sites across 2 countries: United States, United Kingdom
Source: ClinicalTrials.gov record NCT02649894. Inclusion in this directory is not an endorsement.