Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00526058
Status:
COMPLETED
Last Update Posted:
2018-09-14
First Post:
2007-09-05
Brief Title:
HELPApheresis Therapy to Compare the Reduction of LDL Low Density Lipoprotein Cholesterol
Sponsor:
B Braun Medical Inc
Organization:
B Braun Medical Inc
Study Overview
Official Title:
Randomized Multicenter Crossover Study to Compare the Plasmat Futura Heparin Induced Extracorporeal Lower Density Lipo-Protein LDL Precipitation HELP Apheresis System to the Approved Secura System in the Reduction of LDL-c in Patients With Hypercholesterolemia
Status:
COMPLETED
Status Verified Date:
2018-08
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:
FUTURA
Brief Summary:
The primary objective of the study is to demonstrate that the performance of the modified Plasmat Futura HELP Apheresis System is non-inferior to the current FDA approved Plasmat Secura HELP Apheresis System for use under the approved indication of the acute reduction of LDL-cholesterol from the plasma in populations for whom diet has been ineffective and maximum drug therapy has either been ineffective or not tolerated
Detailed Description:
The primary study endpoint is the change in percent measurements of the pre-to-post apheresis LDL measurements between the approved HELP system and the modified HELP system The secondary study endpoints are clinical lab profiles and device parameters analyzed at specific time points throughout the study
Study Oversight
Has Oversight DMC:
None
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?:
None