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

This study has been completed.
Sponsor:
Information provided by:
Gambro Renal Products, Inc.
ClinicalTrials.gov Identifier:
NCT00579202
First received: December 19, 2007
Last updated: December 26, 2007
Last verified: December 2007

December 19, 2007
December 26, 2007
October 2007
November 2007   (final data collection date for primary outcome measure)
For each dialyzer, the perceived ease of priming. [ Time Frame: During priming of each dialyzer ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00579202 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Ease of Use Study for the Gambro Polyflux HD-C4 Small Dialyzer
The Gambro Polyflux HD-C4 Small Ease of Use Study

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

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.

Observational
Not Provided
Not Provided
Not Provided
Non-Probability Sample

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

Hemodialysis
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
November 2007
November 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • n/a routine dialysis patients

Exclusion Criteria:

  • n/a routine dialysis patients
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00579202
07-0002
No
Jeffrey Shideman, Ph.D. / Director US Clinical Affairs, Gambro Renal Products, Inc.
Gambro Renal Products, Inc.
Not Provided
Principal Investigator: Rana Irmindra, M.D. Advanced Dialysis Center
Gambro Renal Products, Inc.
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP