NCT00579202

Ease of Use Study for the Gambro Polyflux HD-C4 Small Dialyzer

The Gambro Polyflux HD-C4 Small Ease of Use Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: Vantive Health LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemodialysis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-10-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2007-12-21
• Last updated: 2025-03-11

Locations

1 site across 1 country: United States