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

The Gambro Polyflux HD-C4 Small Ease of Use Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00579202

Enrollment

Registered

2007-12-21

Start date

2007-10-31

Completion date

2007-11-30

Last updated

2025-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis

Keywords

Dialyzer

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.

Interventions

DEVICEGambro 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.

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* n/a routine dialysis patients

Exclusion criteria

* n/a routine dialysis patients

Design outcomes

Primary

Measure	Time frame
For each dialyzer, the perceived ease of priming.	During priming of each dialyzer

Secondary

Measure	Time frame
Visual assessment of residual blood in the dialyzer after rinse-back and if dialyzer clotted during treatment.	At the completion of each treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026