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NOT YET RECRUITING
NCT06934096
NA

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

Sponsor: Northwell Health

View on ClinicalTrials.gov

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

Official title: Effects of Ultrasound Insonification of the Spleen on Platelet Activity and Coagulation Biomarkers in Healthy Human Subjects

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

39

Start Date

2025-04-15

Completion Date

2026-05-12

Last Updated

2025-04-18

Healthy Volunteers

Yes

Interventions

DEVICE

Ultrasound 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.

Locations (1)

Feinstein Institute for Medical Research

Manhasset, New York, United States