Phase 2 Randomized Study of the Tolerability and Safety of the OsciPulse Device for the Prevention of VTE

Recruiting
99 years or below
All
Phase 2
16 participants needed
1 Location

Brief description of study

Venous thromboembolism (VTE) is a major complication occurring in hospitalized subjects. Although anticoagulants and mechanical prophylaxis are commonly used to prevent VTE it remains a leading cause of complications and death in the hospital population. The objective of this study is to evaluate device design with respect to initial clinical safety and device functionality. The study intervention will be the OsciPulse device system. The OsciPulse system is a noninvasive device that provides rapid compressive force to the calves of the user to modify venous blood flow patterns in immobilized persons. Part 1 participants will be healthy individuals who wear the device for 3 hours and evaluate tolerability and safety of the device on healthy individuals. Part 2 participants will be immobilized for 48 hours and will wear the Oscipulse device for up to 24 hours and the standard of care intermittent compression device for 24 and be asked to evaluate each option.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Medical Research
  • Age: 99 years or below
  • Gender: All
Updated on 12 May 2021. Study ID: 844294

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