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

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ClinicalTrials.gov Identifier: NCT00579202
Recruitment Status : Completed
First Posted : December 21, 2007
Last Update Posted : April 5, 2017
Sponsor:
Collaborator:
Gambro Renal Products, Inc.
Information provided by (Responsible Party):
Baxter Healthcare Corporation

Study Description
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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

Condition or disease Intervention/treatment
Hemodialysis Device: Gambro HD-C4 Small Dialyzer

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.


Study Design
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Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Other
Time Perspective: Other
Official Title: The Gambro Polyflux HD-C4 Small Ease of Use Study
Study Start Date : October 2007
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Groups and Cohorts
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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.

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

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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United States, Maryland
Advanced Dialysis Center
Lanham, Maryland, United States, 20706
Sponsors and Collaborators
Baxter Healthcare Corporation
Gambro Renal Products, Inc.
Investigators
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Principal Investigator: Rana Irmindra, M.D. Advanced Dialysis Center
More Information
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Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00579202     History of Changes
Other Study ID Numbers: 07-0002
First Posted: December 21, 2007    Key Record Dates
Last Update Posted: April 5, 2017
Last Verified: April 2017
Keywords provided by Baxter Healthcare Corporation:
Dialyzer