Ultrasound of the Spleen Utilizing Low-energy (Diagnostic Level) Insonification.

Part of paid clinical trials in Manhasset, New York.

Sponsor
Northwell Health
Study ID
NCT06934096
Status
Not Yet Recruiting

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Conditions

  • Blood Biomarkers
  • Hemostasis
  • Ultrasound

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

  • Ultrasound Pulsed Doppler Imaging System — DEVICE
    Ultrasound pulsed doppler system accompanied with the abdominal curvilinear probe will be used for the purpose of collecting the data for the endpoints.

Study Details

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

Key Dates

Start date
Apr 15, 2025
Status verified
Apr 2025
Primary completion
Apr 21, 2026
Completion
May 12, 2026

Study Design

Enrollment
39 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Focused insonification at enter of spleen
  • Experimental: Prolonged duration Insonification at center of spleen
  • Experimental: Prolonged insonification swept across the spleen

Primary Outcome Measure

To determine whether diagnostic-level ultrasound to the spleen can modulate systemic blood biomarkers of hemostasis [ Time Frame: 4 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Feinstein Institute for Medical ResearchManhassetNew York11030
Maaryj Ahmad
[email protected]
516-562-3757

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By research site
Feinstein Institute for Medical Research· Manhasset, NY

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