HemostasisNCT06934096
Ultrasound of the Spleen Utilizing Low-energy (Diagnostic Level) Insonification.
A study testing Ultrasound Pulsed Doppler Imaging System in people with Hemostasis and Blood Biomarkers, run by Northwell Health at 1 site in United States.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemostasis, Blood Biomarkers, Ultrasound
- What is being tested?
- Ultrasound Pulsed Doppler Imaging System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2026to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
- Prisoners
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Feinstein Institute for Medical Research
Manhasset, New York, 11030
Maaryj Ahmad, 516-562-3757, Mahmad11@northwell.edu
About this study
Official title: 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
- Conditions
- Hemostasis, Blood Biomarkers, Ultrasound
- Being tested
- Ultrasound Pulsed Doppler Imaging System
- Keywords
- Ultrasound of the spleen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Pulsed Doppler Imaging SystemDevice
Ultrasound pulsed doppler system accompanied with the abdominal curvilinear probe will be used for the purpose of collecting the data for the endpoints.
| Study group | Role | What they receive |
|---|---|---|
| Focused insonification at enter of spleen | Experimental | Not described Receives: Device: Ultrasound Pulsed Doppler Imaging System |
| Prolonged duration Insonification at center of spleen | Experimental | Not described Receives: Device: Ultrasound Pulsed Doppler Imaging System |
| Prolonged insonification swept across the spleen | Experimental | Not described Receives: Device: Ultrasound Pulsed Doppler Imaging System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start8 Jan 2026
- Primary completion7 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemostasisStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized from the three groups into two 30-minute stimulation sessions. One session will be active and the other sham. Participants are blinded to treatment group as well as the stimulation session.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934096
- Sponsor's protocol ID
- 24-0307
- Status last verified
- Aug 2026
- First submitted
- 2 Apr 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ultrasound Insonification of the Spleen on Platelet Activity and Coagulation Biomarkers in Healthy Human Subjects
- ClinicalTrials.gov ID
- NCT06934096
- Acronym / sponsor ID
- 24-0307
- Conditions
- Hemostasis, Blood Biomarkers, Ultrasound
- Keywords
- Ultrasound of the spleen
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- GE Healthcare
- Study start
- 8 Jan 2026 (actual)
- Primary completion
- 7 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Participants will be randomized from the three groups into two 30-minute stimulation sessions. One session will be active and the other sham. Participants are blinded to treatment group as well as the stimulation session.
| Arm | Type | Receives |
|---|---|---|
| Focused insonification at enter of spleen | Experimental | Device: Ultrasound Pulsed Doppler Imaging System |
| Prolonged duration Insonification at center of spleen | Experimental | Device: Ultrasound Pulsed Doppler Imaging System |
| Prolonged insonification swept across the spleen | Experimental | Device: Ultrasound Pulsed Doppler Imaging System |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (55 listed)
- 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:
- Individuals who have taken any of the following medications within two weeks of receiving ultrasound delivery:
- Individuals with a substance abuse (alcoholism or other) problem
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound Pulsed Doppler Imaging SystemUltrasound pulsed doppler system accompanied with the abdominal curvilinear probe will be used for the purpose of collecting the data for the endpoints. | Device | Focused insonification at enter of spleen, Prolonged duration Insonification at center of spleen, Prolonged insonification swept across the spleen |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Pulsed Doppler Imaging System in people with Hemostasis and Blood Biomarkers, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 55 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maaryj Ahmad (5165623757, Mahmad11@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine whether diagnostic-level ultrasound to the spleen can modulate systemic blood biomarkers of hemostasis (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.