Ease of Use Study for the Gambro Polyflux HD-C4 Small Dialyzer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00579202|
Recruitment Status : Completed
First Posted : December 21, 2007
Last Update Posted : April 5, 2017
|Condition or disease||Intervention/treatment|
|Hemodialysis||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.
|Study Type :||Observational|
|Actual Enrollment :||24 participants|
|Official Title:||The Gambro Polyflux HD-C4 Small Ease of Use Study|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||November 2007|
- Device: Gambro HD-C4 Small Dialyzer
Involves the use of FDA 510(k) cleared hemodialyzers and will have no impact on the patient's routine dialysis therapy.
- For each dialyzer, the perceived ease of priming. [ Time Frame: During priming of each dialyzer ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00579202
|United States, Maryland|
|Advanced Dialysis Center|
|Lanham, Maryland, United States, 20706|
|Principal Investigator:||Rana Irmindra, M.D.||Advanced Dialysis Center|