Ultrasound of the Spleen for Blood Biomarkers

This study is looking into whether using a special type of ultrasound on the spleen (an organ in your belly that helps filter blood) can change certain substances in your blood related to hemostasis (how your blood clots). Researchers will use an Ultrasound Pulsed Doppler Imaging System to deliver low-energy ultrasound to the spleen. The main goal is to see if these blood changes happen within 4 hours. You can join if you are between 18 and 50 years old, don't have physical disabilities or conditions that would make the procedure unsafe, and are willing to follow all study steps. This study plans to enroll 39 participants and is currently unclear on its recruitment status.

Study design
This is an early-stage, single-center study that will enroll 39 participants. It is randomized, double-blinded, and sham-controlled, meaning some participants will receive a fake treatment without knowing it.
What's involved
Participants will receive 30 minutes of sham stimulation followed by active stimulation within the same group. The study does not specify the number of visits or overall duration.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 4 hours after the intervention, but the overall follow-up duration is not specified.

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NCT06934096

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

Recruiting
NAAges 18–50InterventionalBasic science
Northwell Health
~39 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:Ultrasound Pulsed Doppler Imaging System

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To determine whether diagnostic-level ultrasound to the spleen can modulate systemic blood biomarkers of hemostasis
Measured over 4 hours
Hemostasis
Blood Biomarkers
Ultrasound
1 sites across 1 states
New York1

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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
  • To determine whether diagnostic-level ultrasound to the spleen can modulate systemic blood biomarkers of hemostasis4 hours

    The primary objective is to determine whether diagnostic-level ultrasound to the spleen can modulate systemic blood biomarkers of hemostasis.