Skip to main content
OpenTrials
Completed

NCT Number: NCT00579202

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hemodialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Advanced Dialysis Center

Lanham, Maryland, 20706, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • n/a routine dialysis patients

Exclusion criteria

  • n/a routine dialysis patients

Treatment and study plan

Gambro HD-C4 Small Dialyzer

Device

Involves the use of FDA 510(k) cleared hemodialyzers and will have no impact on the patient's routine dialysis therapy.

Primary outcomes

  1. For each dialyzer, the perceived ease of priming.

    Time frame: During priming of each dialyzer

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Vantive Health LLC

Industry

Collaborators

  • Baxter Healthcare Corporation
  • Gambro Renal Products, Inc.

Registry information

Official study title

The Gambro Polyflux HD-C4 Small Ease of Use Study

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Dec 21, 2007
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.