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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Ultrasound; Hemostasis; Blood Biomarkers
• Intervention / Treatment: Device: Ultrasound Pulsed Doppler Imaging System

• Study Type: Interventional
• Enrollment (Estimated): 39
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maaryj Ahmad; Phone Number: 5165623757; Email: Mahmad11@northwell.edu

Study Locations

• United States
  • New York
    • Manhasset, New York, United States, 11030
      • Feinstein Institute for Medical Research
      • Contact: Maaryj Ahmad; Phone Number: 516-562-3757; Email: Mahmad11@northwell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

1. Provision of signed and dated informed consent form
2. Willingness to comply with all study procedures and availability for the entire study duration
3. Male or female, aged 18 to 50 years
4. 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.
5. Individuals without significant past medical or surgical histories that would render them at a greater risk of harm
6. Individuals that are considered English Proficient due to the study requirements to follow verbal commands during the ultrasound session
7. 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
8. Willing to adhere to the ultrasound study regimen
9. Individuals able to attend all study visits at approximately the same time of day (i.e., 8-12 pm)
10. Individuals able to comprehend the study goals and procedures, and can provide informed consent for participation

Exclusion Criteria:

1. Individuals participating in another research study that may affect the conduct or results of this study
2. Individuals considered substantially overweight or obese via body mass index (BMI > 30)

3. 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
   • history of cancer

4. Individuals who have taken any of the following medications within two weeks of receiving ultrasound delivery:

   • anti-coagulants (warfarin, Xarelto)
   • anti-platelet agent (aspirin, clopidogrel)
   • anti-inflammatory (aspirin, NSAIDs)
   • anti-hypertensive (α-methyldopa)
   • epinephrine-related drugs, norepinephrine-related drugs, and drugs that stimulate release of epinephrine and/or norepinephrine (Micronefrin, Asthmanefrin)
   • immunosuppressive agents (steroids, newer immunomodulatory drugs)
   • alpha and/or beta-adrenoceptor blocking agents
   • anti-seizure medications
   • other medications, supplements, etc. that may interfere with the ultrasound delivery or study results
5. Individuals with a substance abuse (alcoholism or other) problem
6. Individuals that consumed alcohol within 7 days of the baseline visit
7. Individuals currently using or have used cocaine, heroin, marijuana, or other illicit recreational drugs within the past 3 months
8. Prisoners
9. Participant has a history of thrombocytopenia (platelet count <100k)
10. Participant has reported coagulopathy (elevated PT, PTT, elevated activated clotting time (ACT))
11. Participant has internal bleeding, external bleeding, easy bruising
12. Participant has a history of abnormal bleeding or blood disorder, including anemia or anemia-related disorders
13. Participant has a history of thrombocytopenia (platelet count <100k)
14. Participant has a history of coagulopathy, including hemophilia, stroke, pulmonary embolism, myocardial infarction, or deep vein thromboses
15. Participant has a history of conditions that can cause coagulopathic conditions, including atrial fibrillation, heart valve surgery or replacement, hip or knee replacement, or clotting disorders
16. Participants using coagulation- or platelet-modifying therapies such as clotting factor products, emicizumab, desmopressin acetate, epsilon amino caproic acid, heparin and its derivatives, argatroban, desirudin, bivalirudin, dabigatran, apixaban, edoxaban, betrixaban
17. Participant has a history of chronic tobacco use or has ingested nicotine via smoking, vaping, smokeless tobacco, or nicotine patches in the past three months
18. Participant has consumed caffeine within the past 12 hours
19. Participant has received a blood transfusion within 30 days prior to study
20. Participant has a history of neurologic diseases or traumatic brain injury
21. Women of childbearing potential, not using adequate contraception as per investigator judgment or not willing to comply with contraception for the duration of the study
22. Females who are pregnant, lactating or menstruating
23. Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants are risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Focused insonification at enter of spleen	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.
Experimental: Prolonged duration Insonification at center of spleen	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.
Experimental: Prolonged insonification swept across the spleen	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine whether diagnostic-level ultrasound to the spleen can modulate systemic blood biomarkers of hemostasis	The primary objective is to determine whether diagnostic-level ultrasound to the spleen can modulate systemic blood biomarkers of hemostasis.	4 hours

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: GE Healthcare

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2025
• Primary Completion (Estimated): April 21, 2026
• Study Completion (Estimated): May 12, 2026

Study Registration Dates

• First Submitted: April 2, 2025
• First Submitted That Met QC Criteria: April 16, 2025
• First Posted (Actual): April 18, 2025

Study Record Updates

• Last Update Posted (Actual): April 18, 2025
• Last Update Submitted That Met QC Criteria: April 16, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Ultrasound of the spleen
• Other Study ID Numbers: 24-0307

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No