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OpenTrials
Completed

NCT Number: NCT06510062

Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation

Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation

Completed

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Key information

Conditions

Measurement of Circulation on Anatomical Locations of the Body

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ZetrOZ Systems LLC

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
  • Has any preexisting extremity circulation condition

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 Wearable, Long Duration Low-Intensity Device

2.5% Diclofenac Patches

Drug

Topical pain relief gel worn via SAM patch.

Primary outcomes

  1. Blood Flow (Perfusion Unit)

    Time frame: 0 - 1 hour

    Blood Flow Flux through Upper Extremity (Perfusion Unit)

  2. Ultrasound Diathermy (Degrees Centigrade)

    Time frame: 0 - 1 hour

    Temperature Measurement on Body (Degrees Centrigrade)

Sponsors and collaborators

Lead sponsor

ZetrOZ, Inc.

Industry

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 19, 2024
Registry last updated
Mar 6, 2025

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.