Ease of Use Study for the Gambro Polyflux HD-C4 Small Dialyzer
The purpose of the study is to study the ease of use of the Polyflux HD-C4 Small dialyzer under conditions of routine clinical use for hemodialysis
|Official Title:||The Gambro Polyflux HD-C4 Small Ease of Use Study|
- For each dialyzer, the perceived ease of priming. [ Time Frame: During priming of each dialyzer ] [ Designated as safety issue: No ]
- Visual assessment of residual blood in the dialyzer after rinse-back and if dialyzer clotted during treatment. [ Time Frame: At the completion of each treatment ] [ Designated as safety issue: No ]
|Study Start Date:||October 2007|
|Study Completion Date:||November 2007|
|Primary Completion Date:||November 2007 (Final data collection date for primary outcome measure)|
Device: Gambro HD-C4 Small Dialyzer
Market evaluation protocol.
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 strictly aimed at obtaining feedback from the nursing and technical staff regarding the use of the Polyflux HD-C4 Small dialyzer. The dialysis nursing staff will complete ease of use assessments following routine dialysis therapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00579202
|United States, Maryland|
|Advanced Dialysis Center|
|Lanham, Maryland, United States, 20706|
|Principal Investigator:||Rana Irmindra, M.D.||Advanced Dialysis Center|