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OpenTrials
Completed

NCT Number: NCT05259995

Sustained Acoustic Medicine Ultrasound Diathermy Clinical Performance

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

Completed

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Key information

Conditions

Measurement of Diathermy on Anatomical Locations of the Body

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ZetrOZ

Trumbull, Connecticut, 06611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy Volunteer

Exclusion criteria

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

Treatment and study plan

Sustained Acoustic Medicine

Device

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.

Other names: SAM, Wearable Ultrasound Device, Long Duration Ultrasound, LITUS Device, Long Duration Low-Intensity Device

Primary outcomes

  1. Ultrasound Diathermy (Degrees Centigrade)

    Time frame: 0 - 4 hours

    Temperature Measurement On Body (Degrees Centigrade)

Sponsors and collaborators

Lead sponsor

ZetrOZ, Inc.

Industry

Registry information

Official study title

Verification of Performance of Sustained Acoustic Medicine Device Designs Diathermy

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 2, 2022
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.