Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-25 @ 5:43 PM
Study NCT ID:
NCT00579202
Status:
COMPLETED
Last Update Posted:
2025-03-11
First Post:
2007-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ease of Use Study for the Gambro Polyflux HD-C4 Small Dialyzer
Sponsor:
Vantive Health LLC
Organization:
Study Overview
Official Title:
The Gambro Polyflux HD-C4 Small Ease of Use Study
Status:
COMPLETED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: