Ultrasound of the Spleen at Diagnostic Levels to See if Platelet Activity Changes
Official title: Effects of Ultrasound Insonification of the Spleen on Platelet Activity and Coagulation Biomarkers in Healthy Human Subjects
Run by Northwell Health · NCT06934096 · Data updated 2026-11-12
This study tests whether low-energy ultrasound focused on the spleen can alter blood clotting markers in healthy adults aged 18–50.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | All |
| Enrollment | 39 (estimated) |
| Sponsor | Northwell Health Academic / other |
| Drugs / interventions | emicizumab |
| Locations | 1 site (Manhasset, New York) |
| Status | Recruiting |
| Started | January 8, 2026 |
| Main results expected | January 7, 2027 |
| Study ends | January 31, 2027 |
| Registry record updated | August 27, 2026 |
| Trial ID | NCT06934096 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–50 without significant medical history or conditions that would increase risk, who are English-proficient and eligible for ultrasound procedures, willing to comply with all study visits.
✕Probably not a fit
Participants with conditions affecting coagulation or who do not show biomarker changes may not experience a benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a three-cohort, randomized, double-blinded, sham-controlled single-center feasibility trial. Participants receive a 30-minute sham session followed by active ultrasound according to their group: focused spleen center, longer duration at center, or longer duration across the spleen. Blood biomarkers related to platelets and coagulation are measured before and after stimulation to assess local and systemic molecular effects. The study uses a pulsed Doppler ultrasound device to deliver diagnostic-level insonification to the spleen. Outcomes focus on biologic responses rather than clinical events.
Why it matters
Potential benefit: If successful, this approach could reveal a noninvasive way to modulate platelet activity and coagulation with targeted spleen ultrasound.
How similar studies have gone: Prior work in ultrasound-based organ stimulation has shown biological effects in some contexts, but this exact spleen-targeted, diagnostic-level approach is novel and feasibility-focused.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Feinstein Institute for Medical Research
Manhasset, New York, United States Recruiting
Study contacts
- Study coordinator: Maaryj Ahmad
- Email: Mahmad11@northwell.edu
- Phone: 5165623757
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.