The primary objective of the study is to demonstrate that the performance of the modified Plasmat® Futura H.E.L.P. Apheresis System is non-inferior to the current FDA approved Plasmat® Secura H.E.L.P 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.
The primary study endpoint is the change in percent measurements of the pre-to-post apheresis LDL measurements between the approved H.E.L.P. system and the modified H.E.L.P. system. The secondary study endpoints are clinical lab profiles and device parameters analyzed at specific time points throughout the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
18
Randomized to 6 bi-monthly H.E.L.P. therapy treatments with the Plasmat® Secura apheresis system and then cross over to receive 6 bi-monthly treatments with the Plasmat® Futura apheresis system.
Randomized to 6 bi-monthly H.E L.P. therapy treatments with the Plasmat® Futura apheresis system and then cross over to receive 6 bi-monthly treatments with the Plasmat® Secura apheresis system.
Hartford Hospital
Hartford, Connecticut, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Percent Change in Pre- and Post-treatment Reductions of Low-density Lipoprotein Cholesterol (LDL-C) Levels Between the Approved H.E.L.P. System and the Modified H.E.L.P. System.
Time frame: Blood samples for LDL-cholesterol determination will be obtained before and after each treatment from week 0 to week 24..
Percent Change of the Pre and Post Treatment Value
The primary study endpoint is the change in percent measurements of the pre-to-post apheresis LDL measurements. Blood samples for LDL-cholesterol determination will be obtained before and after each treatment. The pooled difference between the pre- and post-treatment LDL level for each apheresis machine will be reported as the primary endpoint for the system performance.
Time frame: Assessment based on LDL-C values obtained pre-and post-treatment, analyzed from week 0 to week 24.
Clinical Lab Profiles (Pre- and Post-Treatment)
Changes in pre- and post-treatment levels of total cholesterol, high-density lipoprotein cholesterol (HDL-C), total triglycerides, lipoprotein (a), fibrinogen, and C-reactive protein.
Time frame: Analyzed at specific time points throughout the study from week 0 to week 24.
Device Parameters
Comparison of plasma flow rate recorded with both systems before treatment, after 500 mL of plasma treated, and at the end of each treatment session.
Time frame: Analyzed at specific time points throughout the study from week 0 to week 24.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.