Sustained Acoustic Medicine Ultrasound Diathermy Clinical Performance

Phase 1

Completed

• Conditions: Measurement of Diathermy on Anatomical Locations of the Body
• Interventions: Device: Sustained Acoustic Medicine

• Registration Number: NCT05259995
• Lead Sponsor: ZetrOZ, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-18
• Study First Submitted QC: 2022-02-18
• Study Start: 2022-02-21
• Study First Posted: 2022-03-02
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-17
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Healthy Volunteer

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sustained Acoustic Medicine Device Group 2	Sustained Acoustic Medicine	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.
Sustained Acoustic Medicine Device Group 1	Sustained Acoustic Medicine	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.

Primary Outcome Measures

Name	Time	Method
Ultrasound Diathermy (Degrees Centigrade)	0 - 4 hours	Temperature Measurement On Body (Degrees Centigrade)

Trial Locations

Locations (1)

ZetrOZ; 🇺🇸 Trumbull, Connecticut, United States