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Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAM Ultrasound Device and Diclofenac Patch 1 | Experimental | 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. |
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| SAM Ultrasound Device and Diclofenac Patch 2 | Experimental | 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. |
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| SAM Ultrasound Device and SAM Patch 1 | Experimental | 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. |
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| SAM Ultrasound Device and SAM Patch 2 | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Flow (Perfusion Unit) | Blood Flow Flux through Upper Extremity (Perfusion Unit) | 0 - 1 hour |
| Ultrasound Diathermy (Degrees Centigrade) | Temperature Measurement on Body (Degrees Centrigrade) | 0 - 1 hour |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George K Lewis, PhD | ZetrOZ Systems LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZetrOZ Systems LLC | Trumbull | Connecticut | 06611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40687068 | Derived | 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. |
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| 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. |
|
|
| 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. |
|
|
| 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. |
|
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| 2.5% Diclofenac Patches | Drug | Topical pain relief gel worn via SAM patch. |
|