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Ease of Use Study for the Gambro Polyflux HD-C4 Small Dialyzer
This study has been completed.
Sponsor:
Baxter Healthcare Corporation
Collaborator:
Gambro Renal Products, Inc.
Information provided by (Responsible Party):
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00579202
First received: December 19, 2007
Last updated: April 4, 2017
Last verified: April 2017
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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:
Detailed Description:
-
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.
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 (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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00579202
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
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 |
| Study First Received: | December 19, 2007 |
| Last Updated: | April 4, 2017 |
Keywords provided by Baxter Healthcare Corporation:
|
Dialyzer |
ClinicalTrials.gov processed this record on September 21, 2017