Clinical Trial

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

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Record status
This record was last updated April 18, 2025 (before its estimated April 21, 2026 completion). Its status may not reflect the trial's current state.
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
Trial Details
NCT Number NCT06934096
Lead Sponsor Northwell Health
Collaborators: GE Healthcare
Conditions Hemostasis, Blood Biomarkers, Ultrasound
Enrollment 39 participants
Start Date 2025-04-15
Primary Completion 2026-04-21 (estimated)
Study Completion 2026-05-12 (estimated)
Updated on ClinicalTrials.gov 2025-04-18