Sustained Acoustic Medicine Ultrasound Diathermy Clinical Performance

ZetrOZ

Status and phase: Completed; Phase 1

Conditions: Measurement of Diathermy on Anatomical Locations of the Body

Treatments: Device: Sustained Acoustic Medicine

Study type: Interventional

Funder types: Industry

Identifiers

NCT05259995

DT-01-2022

Details and patient eligibility

About

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

Enrollment: 54 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Volunteer

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Sustained Acoustic Medicine Device Group 1

Experimental group

Description:

Patients receive treatment from the SAM Ultrasonic Diathermy Device 1 for 4 hours. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.

Treatment:

Device: Sustained Acoustic Medicine

Sustained Acoustic Medicine Device Group 2

Active Comparator group

Description:

Patients receive treatment from the SAM Ultrasonic Diathermy Device 2 for 4 hours. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.

Treatment:

Device: Sustained Acoustic Medicine