Effects of Ultrasound Insonification of the Spleen on Platelet Activity and Coagulation Biomarkers in Healthy Human Subjects
Northwell Health
Summary
This is a three-cohort, randomized, double-blinded , sham-controlled, single-center, early feasibility research trial to determine whether organ-specific biologic effects on platelet activity and coagulation are achievable through selective ultrasound of the spleen utilizing low-energy (diagnostic-level) insonification. * Group 1: Focused insonification at center of the spleen. * Group 2: Prolonged duration insonification at center of the spleen * Group 3: Prolonged duration insonification across the spleen. Participants will receive 30 minutes of sham stimulation in the randomized group that is assigned to them, followed by active stimulation within the same group. Blood biomarkers (local and systemic) will be measured before and at several timepoints after stimulation to measure the molecular and cellular effects of the device
Eligibility
- Age range
- 18–50 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria 1. Provision of signed and dated informed consent form 2. Willingness to comply with all study procedures and availability for the entire study duration 3. Male or female, aged 18 to 50 years 4. Individuals without physical disabilities or conditions/diseases that may make them incapable of undergoing the study procedure or otherwise places them at a greater risk of harm. 5. Individuals without significant past medical or surgical histories that would render them at a greater risk of harm 6. Individuals that are considered English Proficient due to the study requirements to…
Interventions
- DeviceUltrasound Pulsed Doppler Imaging System
Ultrasound pulsed doppler system accompanied with the abdominal curvilinear probe will be used for the purpose of collecting the data for the endpoints.
Location
- Feinstein Institute for Medical ResearchManhasset, New York