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

Starting soon · Not applicable · Has a placebo group

Conditions studied: Hemostasis, Blood Biomarkers, Ultrasound

In brief

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 facts

Study ID

NCT06934096

Run by

Northwell Health

People needed

39

Starts

2025-04-15

Expected to finish

2026-05-12

Last updated by the study team

2025-04-18

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Provision of signed and dated informed consent form
• Willingness to comply with all study procedures and availability for the entire study duration
• Male or female, aged 18 to 50 years
• 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.
• Individuals without significant past medical or surgical histories that would render them at a greater risk of harm
• Individuals that are considered English Proficient due to the study requirements to follow verbal commands during the ultrasound session
• Individuals that are considered active as assessed by type of activity (i.e., walking, running, etc.) and number of hours a week performing the various activities
• Willing to adhere to the ultrasound study regimen
• Individuals able to attend all study visits at approximately the same time of day (i.e., 8-12 pm)
• Individuals able to comprehend the study goals and procedures, and can provide informed consent for participation

You may not qualify if…

• Individuals participating in another research study that may affect the conduct or results of this study
• Individuals considered substantially overweight or obese via body mass index (BMI > 30)
• Individuals having or exhibiting any of the following:
• surgery in the past 90 days
• previous surgery of the spleen or splenectomy, esophagus, lungs, stomach, duodenum, or liver
• recent traumatic injury, including intracerebral hemorrhage and visceral injury
• end stage renal disease and/or uremia
• active malignancy
• previous leukemia and/or lymphoma
• human immunodeficiency virus infection or AIDS
• rheumatoid arthritis or other immune-mediated diseases (e.g. inflammatory bowel disease)
• arrhythmias, including but not limited to, atrial fibrillation, atrial flutter, clinically significant bradycardia, ventricular arrhythmias, and A-V block
• implanted pacemaker or cardioverter/defibrillator (AICD)
• history of stable or unstable angina, myocardial infarction, angioplasty, or coronary arterial by-pass grafting surgery
• history of stroke or TIA
• history of deep venous thrombosis (DVT) and/or pulmonary embolism (PE)
• previous episodes of pancreatitis
• spinal disorders
• chronic pain syndromes
• stage III-IV pressure ulcers
• sickle cell anemia or other anemia syndromes
• diagnosed with fever of unknown origin (FUO)
• previously or currently implanted vagus nerve stimulator
• previously or currently implanted spinal cord stimulator or other chronically implanted electronic medical device
• history of seizures

Where it is running

• Feinstein Institute for Medical Research — Manhasset, New York, United States

Full record on ClinicalTrials.gov

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