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Group A for Deep Vein Thrombosis
N/A
Waitlist Available
Led By Adam Cuker, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours
Awards & highlights
Study Summary
OsciPulse Device for the Prevention of VTE
Eligible Conditions
- Deep Vein Thrombosis
- Pulmonary Embolism
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1 - Safety Assessment Through Collection of Adverse Events
Part 1 - Subject's Response to Tolerability Questionnaire
Part 2 - Safety Assessment Through Collection of Adverse Events.
+1 moreSecondary outcome measures
Hemodynamic impact as measured by center line flow in mL/mL
Hemodynamic impact as measured by center line flow velocity in cm/s.
Hemodynamic impact as measured by valve sinus forward flow in mL/mL
+1 moreTrial Design
2Treatment groups
Active Control
Group I: Group AActive Control1 Intervention
Group A will wear the OsciPulse device for the first 3 hours then switch to the standard IPC device for the second 3 hours.
Group II: Group BActive Control1 Intervention
Group B will wear the standard IPC device for the first 3 hours then switch to the OsciPulse device for the second 3 hours.
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,260 Total Patients Enrolled
3 Trials studying Deep Vein Thrombosis
1,056 Patients Enrolled for Deep Vein Thrombosis
OsciFlex LLCIndustry Sponsor
2 Previous Clinical Trials
16 Total Patients Enrolled
Adam Cuker, MDPrincipal InvestigatorUniversity of Pennsylvania
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