NCT05259995

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2022

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

February 21, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 2, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

February 18, 2022

Last Update Submit

February 17, 2023

Conditions

Measurement of Diathermy on Anatomical Locations of the Body

Outcome Measures

Primary Outcomes (1)

  • Ultrasound Diathermy (Degrees Centigrade)

    Temperature Measurement On Body (Degrees Centigrade)

    0 - 4 hours

Study Arms (2)

Sustained Acoustic Medicine Device Group 1

EXPERIMENTAL

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.

Device: Sustained Acoustic Medicine

Sustained Acoustic Medicine Device Group 2

ACTIVE COMPARATOR

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.

Device: Sustained Acoustic Medicine

Interventions

Sustained Acoustic MedicineDEVICE

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.

Also known as: SAM, Wearable Ultrasound Device, Long Duration Ultrasound, LITUS Device, Long Duration Low-Intensity Device
Sustained Acoustic Medicine Device Group 1Sustained Acoustic Medicine Device Group 2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy Volunteer

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ZetrOZ

Trumbull, Connecticut, 06611, United States

Location

Related Publications (1)

  • Rigby JH, Taggart RM, Stratton KL, Lewis GK Jr, Draper DO. Intramuscular Heating Characteristics of Multihour Low-Intensity Therapeutic Ultrasound. J Athl Train. 2015 Nov;50(11):1158-64. doi: 10.4085/1062-6050-50.11.03. Epub 2015 Oct 28.

    PMID: 26509683BACKGROUND

Study Officials

  • George Lewis, PHD

    ZetrOZ, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2022

First Posted

March 2, 2022

Study Start

February 21, 2022

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)