NCT06934096 · Northwell Health
Ultrasound of the Spleen Utilizing Low-energy (Diagnostic Level) Insonification.
What this study is about
This is a three-group of participants, randomly assigned, 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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
To determine whether diagnostic-level ultrasound to the spleen can modulate systemic blood biomarkers of hemostasis
Time frame: 4 hours
The primary objective is to determine whether diagnostic-level ultrasound to the spleen can modulate systemic blood biomarkers of hemostasis.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
- history of cancer
- 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
- Individuals with a substance abuse (alcoholism or other) problem
- Individuals that consumed alcohol within 7 days of the baseline visit
- Individuals currently using or have used cocaine, heroin, marijuana, or other illicit recreational drugs within the past 3 months
- Participant has a history of thrombocytopenia (platelet count \<100k)
- Participant has reported coagulopathy (elevated PT, PTT, elevated activated clotting time (ACT))
- Participant has internal bleeding, external bleeding, easy bruising
- Participant has a history of abnormal bleeding or blood disorder, including anemia or anemia-related disorders
- Participant has a history of thrombocytopenia (platelet count \<100k)
- Participant has a history of coagulopathy, including hemophilia, stroke, pulmonary embolism, myocardial infarction, or deep vein thromboses
- 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
- 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
- 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
- Participant has consumed caffeine within the past 12 hours
- Participant has received a blood transfusion within 30 days prior to study
- Participant has a history of neurologic diseases or traumatic brain injury
- 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
- Females who are pregnant, lactating or menstruating
- 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
- Manhasset, New York
Collaborators
GE Healthcare
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 27, 2026 · Source of record for eligibility and locations