Can sound waves to the spleen alter blood clotting?

NCT ID NCT06934096

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

Researchers are testing whether low-energy ultrasound aimed at the spleen can change blood clotting activity in healthy adults. The trial involves three groups, each receiving a different pattern of ultrasound exposure, and compares the effects against a sham (inactive) procedure. Blood samples are taken before and after to measure clotting markers. This early study aims to see if a non-drug approach could influence how blood clots.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Low-energy diagnostic-level ultrasound applied to the spleen
What this could lead to
If it works, this could point toward a non-drug way to influence blood clotting, which might help prevent or treat clotting disorders.
What could go wrong
This is an early feasibility study with a small number of healthy participants, so results may not apply to patients. The effect may be too weak or inconsistent to be useful.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 39 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Contacts and locations

Locations

  • Feinstein Institute for Medical Research

    RECRUITING

    Manhasset, New York, 11030, United States

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