Sustained Acoustic Medicine Ultrasound Diathermy Clinical Performance
NCT ID: NCT05259995
Last Updated: 2023-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
54 participants
INTERVENTIONAL
2022-02-21
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sustained Acoustic Medicine Device Group 1
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.
Sustained Acoustic Medicine
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.
Sustained Acoustic Medicine Device Group 2
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
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.
Interventions
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Sustained Acoustic Medicine
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Has an active infection, open sores, or wounds in the treatment area.
18 Years
70 Years
ALL
Yes
Sponsors
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ZetrOZ, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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George Lewis, PHD
Role: PRINCIPAL_INVESTIGATOR
ZetrOZ, Inc.
Locations
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ZetrOZ
Trumbull, Connecticut, United States
Countries
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References
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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.
Other Identifiers
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DT-01-2022
Identifier Type: -
Identifier Source: org_study_id
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