Expired Study
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Lanham, Maryland 20706


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


Study summary:

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.


Criteria:

Inclusion Criteria: - n/a routine dialysis patients Exclusion Criteria: - n/a routine dialysis patients


Study is Available At:


Original ID:

07-0002


NCT ID:

NCT00579202


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

The Gambro Polyflux HD-C4 Small Ease of Use Study


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Baxter Healthcare Corporation


Oversight Authority:

United States: Gambro Renal Products, Inc. - Market Evaluation Study


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

24


Enrollment Type:

Actual


Overall Contact Information

Official Name:Rana Irmindra, M.D.
Principal Investigator
Advanced Dialysis Center

Study Dates

Start Date:October 2007
Completion Date:November 2007
Completion Type:Actual
Primary Completion Date:November 2007
Primary Completion Type:Actual
Verification Date:April 2017
Last Changed Date:April 4, 2017
First Received Date:December 19, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure:For each dialyzer, the perceived ease of priming.
Time Frame:During priming of each dialyzer
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:Gambro HD-C4 Small Dialyzer
Description:Involves the use of FDA 510(k) cleared hemodialyzers and will have no impact on the patient's routine dialysis therapy.

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Baxter Healthcare Corporation
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Gambro Renal Products, Inc.

Samples and Retentions

Study Population: The dialysis nursing staff will complete ease of use assessments following routine dialysis therapy of adult (≥ 18 years of age) patients
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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