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Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation

NCT06510062 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2025-03-06

No results posted yet for this study

Summary

Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation

Conditions

  • Measurement of Circulation on Anatomical Locations of the Body

Interventions

DEVICE

Sustained Acoustic Medicine

The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity delivering 18,720 Joules of ultrasound per 4 hour treatment.

DEVICE

Sustained Acoustic Medicine

The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity delivering 18,720 Joules of ultrasound per 4 hour treatment.

DEVICE

Sustained Acoustic Medicine

The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity delivering 18,720 Joules of ultrasound per 4 hour treatment.

DEVICE

Sustained Acoustic Medicine

The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity delivering 18,720 Joules of ultrasound per 4 hour treatment.

DRUG

2.5% Diclofenac Patches

Topical pain relief gel worn via SAM patch.

Sponsors & Collaborators

  • ZetrOZ, Inc.

    lead INDUSTRY

Principal Investigators

  • George K Lewis, PhD · ZetrOZ Systems LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-07-22
Primary Completion
2024-09-30
Completion
2024-12-31
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 NCT06510062 on ClinicalTrials.gov