Back to resultsSustained Acoustic Medicine Ultrasound Diathermy Clinical Performance
Primary Purpose
Measurement of Diathermy on Anatomical Locations of the Body
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sustained Acoustic Medicine
Sponsored by
About this trial
This is an interventional treatment trial for Measurement of Diathermy on Anatomical Locations of the Body
Eligibility Criteria
Inclusion Criteria:
• Healthy Volunteer
Exclusion Criteria:
- Is pregnant/nursing.
- Has an active infection, open sores, or wounds in the treatment area.
Sites / Locations
- ZetrOZ
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sustained Acoustic Medicine Device Group 1
Sustained Acoustic Medicine Device Group 2
Arm 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.
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.
Outcomes
Primary Outcome Measures
Ultrasound Diathermy (Degrees Centigrade)
Temperature Measurement On Body (Degrees Centigrade)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05259995
Brief Title
Sustained Acoustic Medicine Ultrasound Diathermy Clinical Performance
Official Title
Verification of Performance of Sustained Acoustic Medicine Device Designs Diathermy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 21, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ZetrOZ, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to measure diathermy performance of Sustained Acoustic Medicine Devices with commercially available ultrasound gel coupling patches.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Measurement of Diathermy on Anatomical Locations of the Body
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sustained Acoustic Medicine Device Group 1
Arm Type
Experimental
Arm 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.
Arm Title
Sustained Acoustic Medicine Device Group 2
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Sustained Acoustic Medicine
Other Intervention Name(s)
SAM, Wearable Ultrasound Device, Long Duration Ultrasound, LITUS Device, Long Duration Low-Intensity Device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ultrasound Diathermy (Degrees Centigrade)
Description
Temperature Measurement On Body (Degrees Centigrade)
Time Frame
0 - 4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
• Healthy Volunteer
Exclusion Criteria:
Is pregnant/nursing.
Has an active infection, open sores, or wounds in the treatment area.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Lewis, PHD
Organizational Affiliation
ZetrOZ, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
ZetrOZ
City
Trumbull
State/Province
Connecticut
ZIP/Postal Code
06611
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26509683
Citation
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.
Results Reference
background
Learn more about this trial
Sustained Acoustic Medicine Ultrasound Diathermy Clinical Performance
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