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HDL Therapeutics PDS-2™ System for Hypercholesterolemia
N/A
Waitlist Available
Research Sponsored by HDL Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months
Awards & highlights
Summary
Assess the effect on coronary atheroma of serial infusions of autologous selectively delipidated HDL/preβ enriched plasma following use of HDL Therapeutics PDS-2™ System
Eligible Conditions
- Hypercholesterolemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in coronary atheroma
Side effects data
From 2005 Phase 3 trial • 80 Patients • NCT0018068725%
Nausea and Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control
IP Aerosolized Normal Saline
Nebulised Bupivacaine Intraperitoneally
Injected Bupivacaine Intraperitoneally
Trial Design
1Treatment groups
Experimental Treatment
Group I: HDL Therapeutics PDS-2™ SystemExperimental Treatment1 Intervention
Serial infusions of autologous selectively delipidated HDL/preβ enriched plasma following use of HDL Therapeutics PDS-2™ System
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Who is running the clinical trial?
HDL TherapeuticsLead Sponsor
MedStar Heart and Vascular InstituteUNKNOWN
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