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Biological Effects of Ultrasound Insonification of the Spleen

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ClinicalTrials.gov Identifier: NCT03548116
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
General Electric
Information provided by (Responsible Party):
John Pellerito, Northwell Health

Brief Summary:
This is a six-cohort, double-blinded, randomized, sham-controlled feasibility trial to determine whether organ-specific biological effects are achievable through selective ultrasound of the spleen utilizing low-energy insonification.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Device: Ultrasound Device: Sham Ultrasound Not Applicable

Detailed Description:

This study will consist of three study visits. At the screening visit, individuals will be asked to undergo a physical and neurological examination, a blood draw of 4 teaspoons, and a urine pregnancy test if of childbearing potential.

The participants that clear study screening will be randomized to one of six groups. The groups consist of: sham insonification at the hilum; half-powered insonification at the hilum; full-powered insonification at the hilum; sham insonification at the lower, middle, and upper spleen; half-powered insonification at the lower, middle, and upper spleen; and full-powered insonification at the lower, middle, and upper spleen.

At the baseline visit, individuals will be asked to undergo a physical and neurological examination and a blood draw of 7 teaspoons before receiving ultrasound as per their assigned group. These individuals will then be asked to undergo a blood draw of 5 teaspoons at 1-hour and 2-hours after the ultrasound.

Individuals will be asked to return 24 hours later for the follow-up visit, which will include a physical and neurological examination and a blood draw of 9 teaspoons.

Upon completion of the study, participants will receive compensation for their time and travel expenses for the baseline and follow-up visits.

The blood samples collected before insonification, one hour after insonification, two hours after insonification, and twenty-four hours after insonification will be assessed for changes in biomarkers (substances in the body that indicate the status of a biological process or condition). These biomarkers include cytokines (proteins involved in the immune response), norepinephrine (chemical in the body that transmits signals), glucose (sugar in the blood), and blood cells that are involved in breathing, clotting, and the immune response.

The study will be considered complete after completion of enrollment (10 participants in each group, for a study total of 60 participants), completion of study procedures by all participants, and the completion of analysis of identifiable study data.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: After a screened individual is deemed eligible for continued participation, a study investigator will enter the participant's information into a randomization portal in order to receive the group assignment.
Masking: Double (Participant, Investigator)
Masking Description: The study participants will be blinded to their group assignment for the entire duration of the study. The study investigators will also be blinded to participant assignments on this study, except for the investigators performing the ultrasound procedure, co-investigators randomizing the participants, and co-investigators involved in the study's monitoring.
Primary Purpose: Basic Science
Official Title: Biological Effects of Ultrasound Insonification of the Spleen
Actual Study Start Date : April 23, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Sham Comparator: Group 1
Individuals will receive sham non-imaging mode ultrasound (control group) delivered to just the spleen's hilum (area of spleen that allows passage of blood vessels, lymphatic vessels, and nerves).
Device: Sham Ultrasound
This study involves a specially designed ultrasound being placed against the abdomen of an individual in order to administer sham insonification to the spleen as specified by the individual's assigned study group.

Experimental: Group 2
Individuals will receive half-powered non-imaging mode ultrasound delivered to just the spleen's hilum (area of spleen that allows passage of blood vessels, lymphatic vessels, and nerves).
Device: Ultrasound
This study involves a specially designed ultrasound being placed against the abdomen of an individual in order to administer low levels of insonification to the spleen as specified by the individual's assigned study group.

Experimental: Group 3
Individuals will receive full-powered non-imaging mode ultrasound delivered to just the spleen's hilum (area of spleen that allows passage of blood vessels, lymphatic vessels, and nerves).
Device: Ultrasound
This study involves a specially designed ultrasound being placed against the abdomen of an individual in order to administer low levels of insonification to the spleen as specified by the individual's assigned study group.

Sham Comparator: Group 4
Individuals will receive sham non-imaging mode ultrasound (control group) delivered to the lower, middle, and upper spleen based on the spleen's size.
Device: Sham Ultrasound
This study involves a specially designed ultrasound being placed against the abdomen of an individual in order to administer sham insonification to the spleen as specified by the individual's assigned study group.

Experimental: Group 5
Individuals will receive half-powered non-imaging mode ultrasound delivered to the lower, middle, and upper spleen based on the spleen's size.
Device: Ultrasound
This study involves a specially designed ultrasound being placed against the abdomen of an individual in order to administer low levels of insonification to the spleen as specified by the individual's assigned study group.

Experimental: Group 6
Individuals will receive full-powered non-imaging mode ultrasound delivered to the lower, middle, and upper spleen based on the spleen's size.
Device: Ultrasound
This study involves a specially designed ultrasound being placed against the abdomen of an individual in order to administer low levels of insonification to the spleen as specified by the individual's assigned study group.




Primary Outcome Measures :
  1. Anti-inflammatory Response [ Time Frame: The primary outcome will be assessed before ultrasound and at 1-hour, 2-hours, and 24-hours after receiving ultrasound. ]
    The primary outcome to determine whether diagnostic-level ultrasound to the spleen has a biological effect is measured as a statistically significant change in the level of biomarkers associated with the inflammatory response following delivery of ultrasound.


Secondary Outcome Measures :
  1. Transient Tissue Displacement [ Time Frame: The secondary outcome will be assessed approximately every 15 seconds during the approximately 10-minute ultrasound. ]
    The secondary outcome to determine whether ultrasound delivery to the spleen leads to transient tissue displacement that is correlated to organ-specific biological effects is measured as a statistically significant correlation between the magnitude of transient displacement and the biological effects.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Individuals between 18 and 45 years of age
  • Individuals without physical disabilities or conditions/diseases that may make them incapable of undergoing the study procedures 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
  • Individuals able to attend all study visits at approximately the same time of day (i.e., 8 - 12 pm)
  • Individuals that are able to comprehend the study goals and procedures, and are able to 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 (≥ 29)
  • 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)
    • a 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
    • history of thrombosis or bleeding disorders
    • stage III-IV pressure ulcers
    • sickle cell anemia or other anemia syndromes
    • monocytosis
    • thrombocytopenia
    • diagnosed with fever of unknown origin (FUO)
    • previously or currently implanted vagus nerve stimulator
    • previously or currently implanted spinal cord stimulator
    • other chronically-implanted electronic medical device
    • history of seizures
    • history of cancer
  • Individuals who have taken any of the following medications within one week of receiving ultrasound delivery:

    • anti-coagulant (Coumadin, Xarelto)
    • anti-platelet (aspirin, Plavix)
    • 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 4 days of the baseline visit
  • Individuals currently using or have used tobacco or nicotine products within the past 1 month
  • Individuals currently using or have used recreational drugs within the past 1 month
  • Pregnant women
  • Prisoners

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548116


Contacts
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Contact: Richard D Ramdeo 516-562-3634 rramdeo1@northwell.edu

Locations
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United States, New York
Northwell Health's The Feinstein Institute for Medical Research Recruiting
Manhasset, New York, United States, 11030
Contact: Richard Ramdeo    516-562-3634    rramdeo1@northwell.edu   
Sponsors and Collaborators
John Pellerito
General Electric
Investigators
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Principal Investigator: John Pellerito, MD Northwell Health

Additional Information:
Publications:
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Responsible Party: John Pellerito, Vice Chairman of Education, Department of Radiology; Director, Peripheral Vascular Laboratory and the Body Imaging Fellowship Program, Northwell Health
ClinicalTrials.gov Identifier: NCT03548116     History of Changes
Other Study ID Numbers: 17-0859
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Currently, there are no plans to make individual participant data available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by John Pellerito, Northwell Health:
Healthy Volunteer
Ultrasound
Insonification
Spleen