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

Hemodialysis Clinical Trial

Official title:

The Gambro Polyflux HD-C4 Small Ease of Use Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00579202
• Other study ID #: 07-0002
• Status: Completed
• Phase: N/A
• First received: December 19, 2007
• Last updated: April 4, 2017
• Start date: October 2007
• Est. completion date: November 2007

Study information

• Verified date: April 2017
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• n/a routine dialysis patients

Exclusion Criteria:

• n/a routine dialysis patients

Related Conditions & MeSH terms

• Hemodialysis

Intervention

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.

Locations

Country	Name	City	State
United States	Advanced Dialysis Center	Lanham	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation	Gambro Renal Products, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	For each dialyzer, the perceived ease of priming.		During priming of each dialyzer
Secondary	Visual assessment of residual blood in the dialyzer after rinse-back and if dialyzer clotted during treatment.		At the completion of each treatment