Ease of Use Study for the Gambro Polyflux HD-C4 Small Dialyzer
Completed
- Conditions
- Hemodialysis
- Registration Number
- NCT00579202
- Lead Sponsor
- Vantive Health LLC
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- n/a routine dialysis patients
Exclusion Criteria
- n/a routine dialysis patients
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method For each dialyzer, the perceived ease of priming. During priming of each dialyzer
- Secondary Outcome Measures
Name Time Method Visual assessment of residual blood in the dialyzer after rinse-back and if dialyzer clotted during treatment. At the completion of each treatment
Trial Locations
- Locations (1)
Advanced Dialysis Center
🇺🇸Lanham, Maryland, United States