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

Sponsored by:	Gambro Renal Products, Inc.
Information provided by:	Gambro Renal Products, Inc.
ClinicalTrials.gov Identifier:	NCT00579202

Purpose

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

Condition	Intervention
Hemodialysis	Device: Gambro HD-C4 Small Dialyzer

MedlinePlus related topics: Dialysis Kidney Failure

U.S. FDA Resources

Study Type:	Observational
Official Title:	The Gambro Polyflux HD-C4 Small Ease of Use Study

Further study details as provided by Gambro Renal Products, Inc.:

Primary Outcome Measures:

For each dialyzer, the perceived ease of priming. [ Time Frame: During priming of each dialyzer ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	24
Study Start Date:	October 2007
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Intervention Details:

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The dialysis nursing staff will complete ease of use assessments following routine dialysis therapy of adult (≥ 18 years of age) patients

Criteria

Inclusion Criteria:

n/a routine dialysis patients

Exclusion Criteria:

n/a routine dialysis patients

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00579202

Locations

United States, Maryland
Advanced Dialysis Center
Lanham, Maryland, United States, 20706

Sponsors and Collaborators

Gambro Renal Products, Inc.

Investigators

Principal Investigator:

Rana Irmindra, M.D.

Advanced Dialysis Center

More Information

Responsible Party:	Gambro Renal Products, Inc. ( Jeffrey Shideman, Ph.D. / Director US Clinical Affairs )
Study ID Numbers:	07-0002
Study First Received:	December 19, 2007
Last Updated:	December 26, 2007
ClinicalTrials.gov Identifier:	NCT00579202
Health Authority:	United States: Gambro Renal Products, Inc. - Market Evaluation Study

Keywords provided by Gambro Renal Products, Inc.:

Dialyzer

ClinicalTrials.gov processed this record on January 16, 2009