Sustained Acoustic Medicine Ultrasound Diathermy Clinical Performance

Verification of Performance of Sustained Acoustic Medicine Device Designs Diathermy

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05259995

Enrollment

Registered

2022-03-02

Start date

2022-02-21

Completion date

2022-06-30

Last updated

2023-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Measurement of Diathermy on Anatomical Locations of the Body

Brief summary

The purpose of this study is to measure diathermy performance of Sustained Acoustic Medicine Devices with commercially available ultrasound gel coupling patches.

Interventions

DEVICESustained 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

• Healthy Volunteer

Exclusion criteria

* Is pregnant/nursing. * Has an active infection, open sores, or wounds in the treatment area.

Design outcomes

Primary

Measure	Time frame	Description
Ultrasound Diathermy (Degrees Centigrade)	0 - 4 hours	Temperature Measurement On Body (Degrees Centigrade)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026