A Randomized Pilot Study of the Efficacy of the OsciPulse System for the Reduction of Serum D-dimer
Status: Withdrawn
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of this study is to assess the safety and efficacy of the OsciPulse System in reducing serum d-dimer levels in hospitalized ischemic stroke patients.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• Adult aged ≥ 18 years old
• Admitted to the Neuro Intensive Care Unit or Intermediate Neuro Care Unit with a diagnosis of ischemic stroke
• Last known normal \< 24 hours.
• NIH stroke score ≥5
• Weakness in at least one leg (≥ 1 point on the NIHSS lower extremity motor scores, items 6A and 6B)
• Prescribed mechanical therapy for DVT prophylaxis.
Locations
United States
Pennsylvania
University of Pennsylvania
Philadelphia
Time Frame
Start Date: 2022-12
Completion Date: 2023-03
Treatments
Active_comparator: Control Arm
Subjects will receive standard of care intermittent compression therapy using the current devices used in the clinical space.
Experimental: Study Arm
Subjects will receive compression therapy from the OsciPulse system.
Authors
Related Therapeutic Areas
Sponsors
Leads: OsciFlex LLC
Collaborators: University of Pennsylvania