Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

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
History of Changes
  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
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 ]
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
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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

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: Jeffrey Shideman, Ph.D. / Director US Clinical Affairs, Gambro Renal Products, Inc.
ClinicalTrials.gov Identifier: NCT00579202     History of Changes
Other Study ID Numbers: 07-0002 
Study First Received: December 19, 2007
Last Updated: December 26, 2007
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 September 23, 2016