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Biological Effects of Ultrasound Insonification of the Spleen

NCT03548116 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2021-12-14

No results posted yet for this study

Summary

This is a seven-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.

Conditions

  • Healthy Volunteer

Interventions

DEVICE

Ultrasound

A specially designed ultrasound will be placed against the abdomen of an individual in order to administer low levels of insonification to the spleen.

DEVICE

Sham Ultrasound

A specially designed ultrasound will be placed against the abdomen of an individual in order to administer sham insonification to the spleen.

Sponsors & Collaborators

  • General Electric

    collaborator INDUSTRY

  • John Pellerito

    lead OTHER

Principal Investigators

  • John Pellerito, MD · Northwell Health

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-23
Primary Completion
2020-03-13
Completion
2022-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03548116 on ClinicalTrials.gov