Trials / Completed
CompletedNCT00659724
Ease of Use and Blood Clotting for the Gambro Polyflux HD-C4 Big Dialyzer
The Gambro Polyflux HD-C4 Big Ease Of Use And Thrombogenicity Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 33 (actual)
- Sponsor
- Vantive Health LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to collect information on the ease of use and thrombogenicity of the Polyflux HD-C4 Big and Fresenius Optiflux 180NR or 200NR dialyzers under conditions of routine clinical use for hemodialysis.
Detailed description
This ease of use study involves the use of FDA 510(k) cleared hemodialyzers and will have no impact on the patient's routine dialysis therapy. This study is aimed at obtaining feedback from the nursing and technical staff regarding the use and thrombogenicity of the Polyflux HD-C4 Big, and Fresenius Optiflux 180NR or 200NR dialyzers. The dialysis nursing staff will complete ease of use and thrombogenicity assessments following routine dialysis therapy. Any adverse events will be tracked for the study patients.
Conditions
Timeline
- Start date
- 2008-03-01
- Primary completion
- 2008-05-01
- Completion
- 2008-05-01
- First posted
- 2008-04-16
- Last updated
- 2025-07-24
- Results posted
- 2011-06-27
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00659724. Inclusion in this directory is not an endorsement.