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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00579202
First Posted: December 21, 2007
Last Update Posted: April 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Gambro Renal Products, Inc.
Information provided by (Responsible Party):
Baxter Healthcare Corporation
  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

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Other
Official Title: The Gambro Polyflux HD-C4 Small Ease of Use Study

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Primary Outcome Measures:
  • For each dialyzer, the perceived ease of priming. [ Time Frame: During priming of each dialyzer ]

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 ]

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:
    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.
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00579202


Locations
United States, Maryland
Advanced Dialysis Center
Lanham, Maryland, United States, 20706
Sponsors and Collaborators
Baxter Healthcare Corporation
Gambro Renal Products, Inc.
Investigators
Principal Investigator: Rana Irmindra, M.D. Advanced Dialysis Center
  More Information

Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00579202     History of Changes
Other Study ID Numbers: 07-0002
First Submitted: December 19, 2007
First Posted: December 21, 2007
Last Update Posted: April 5, 2017
Last Verified: April 2017

Keywords provided by Baxter Healthcare Corporation:
Dialyzer