Ultrasound of the Spleen Utilizing Low-energy (Diagnostic Level) Insonification.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorNorthwell Health
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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)
surgery in the past 90 days
previous surgery of the spleen or splenectomy, esophagus, lungs, stomach, duodenum, or liver
Trial design
Design model
Parallel
Treatments tested in this trial
Ultrasound Pulsed Doppler Imaging System
DeviceUltrasound pulsed doppler system accompanied with the abdominal curvilinear probe will be used for the purpose of collecting the data for the endpoints.
Treatment groups
39 Participants
are divided into 3 treatment groupsGroup A: Focused insonification at enter of spleenExperimental treatment 1 intervention
Group B: Prolonged duration Insonification at center of spleenExperimental treatment 1 intervention
Group C: Prolonged insonification swept across the spleenExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
4 hoursSponsors and contacts
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Northwell Health
Lead sponsor
GE Healthcare
Collaborator
Source ClinicalTrials.gov