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

NCT06934096 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2025-04-18

No results posted yet for this study

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

Conditions

  • Hemostasis
  • Blood Biomarkers
  • Ultrasound

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.

Sponsors & Collaborators

  • GE Healthcare

    collaborator INDUSTRY

  • Northwell Health

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-04-15
Primary Completion
2026-04-21
Completion
2026-05-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06934096 on ClinicalTrials.gov