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

NCT06934096 | Not Yet Recruiting DMC

• 1 other identifier: 24-0307
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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) 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

Keywords

Ultrasound of the spleen

Outcome Measures

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.

  4 hours

Study Arms (3)

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

Interventions

Ultrasound Pulsed Doppler Imaging System DEVICE

Ultrasound pulsed doppler system accompanied with the abdominal curvilinear probe will be used for the purpose of collecting the data for the endpoints.

Focused insonification at enter of spleen; Prolonged duration Insonification at center of spleen; Prolonged insonification swept across the spleen

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead
• GE Healthcare: collaborator

Study Sites (1)

Feinstein Institute for Medical Research

Manhasset, New York, 11030, United States

Location

Central Study Contacts

Maaryj Ahmad

CONTACT

5165623757; Mahmad11@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 18, 2025
• Study Start: April 15, 2025
• Primary Completion: April 21, 2026
• Study Completion (Estimated): May 12, 2026
• Last Updated: April 18, 2025

Record last verified: 2025-04

Locations

US (1)