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Open-label, non-randomized, prospective, multi-center, self-controlled clinical study.
Eligible patients will receive combined treatment on both upper arms, included 1 or 2 SofWave treatments and 4 Pure Impact treatments. At the first session (Visit 1), subjects undergo SofWave treatment, and may undergo Pure Impact treatment also at the same visit. If conducting the two procedures on the same day, Pure Impact shall be applied before SofWave. If the procedures are done in separate visits, schedule the Pure Impact 2-7 days after the SofWave procedure. If the two treatments are conducted on the same day, then the second Pure Impact session will be 7-10 days after; similarly, the third and fourth Pure Impact sessions will be performed 7-10 days apart following the previous session. The last (fourth) Pure Impact treatment may occur on the same day or after the optional second SofWave treatment. If conducting the two procedures on the same day, Pure Impact shall be applied before SofWave. If the procedures are done in separate visits, schedule the SofWave 2-7 days after the fourth Pure Impact procedure.
All patients will return to the clinic for two follow-up visits at 4±1 weeks and at 12±2 weeks post last treatment (FU1 and FU2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lax Tissue and Muscles | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sofwave and Pure Impact | Device | The Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues. Pure Impact is an EMS module. This module is wirelessly connected to and controlled by the SofWave console. It functions independently from the existing ultrasound module. Pure Impact generates electrical impulses, which are delivered through electrodes on the skin in direct proximity to the muscles to be stimulated. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in the appearance of lax skin | Rate of improvement in the appearance of lax skin and in the strength and tone muscles in the upper arms following Sofwave and Pure Impact combined treatment based on Global Aesthetic Improvement Scale, as evaluated by independent masked reviewers. | 3 months post treatment follow-up visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | United States |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |