Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation
NCT ID: NCT06510062
Last Updated: 2025-03-06
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
67 participants
INTERVENTIONAL
2024-07-22
2024-12-31
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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SAM Ultrasound Device and Diclofenac Patch 1
Patients receive treatment from the SAM Ultrasonic Diathermy Device 1 hour with 2.5% diclofenac ultrasound gel patch on right forearm. 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.
2.5% Diclofenac Patches
Topical pain relief gel worn via SAM patch.
SAM Ultrasound Device and Diclofenac Patch 2
Patients receive treatment from the SAM Ultrasonic Diathermy Device 1 hour with 2.5% diclofenac ultrasound gel patch on left forearm. 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.
2.5% Diclofenac Patches
Topical pain relief gel worn via SAM patch.
SAM Ultrasound Device and SAM Patch 1
Patients receive treatment from the SAM Ultrasonic Diathermy Device 1 hour with standard ultrasound gel patch on right forearm. 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.
SAM Ultrasound Device and SAM Patch 2
Patients receive treatment from the SAM Ultrasonic Diathermy Device 1 hour with standard ultrasound gel patch on left forearm. 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.
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
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
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.
2.5% Diclofenac Patches
Topical pain relief gel worn via SAM patch.
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
* Has any preexisting extremity circulation condition
18 Years
50 Years
ALL
Yes
Sponsors
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ZetrOZ, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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George K Lewis, PhD
Role: PRINCIPAL_INVESTIGATOR
ZetrOZ Systems LLC
Locations
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ZetrOZ Systems LLC
Trumbull, Connecticut, United States
Countries
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References
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Scanzuso A, Hendren T, Egmont M, Zarkar J, Roberge M. Sustained acoustic medicine increases local circulation with a diclofenac delivery patch: a randomized placebo controlled study. Front Med Technol. 2025 Jul 4;7:1552294. doi: 10.3389/fmedt.2025.1552294. eCollection 2025.
Other Identifiers
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CR-01-2024
Identifier Type: -
Identifier Source: org_study_id
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