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Open-label, non-randomized, prospective, multi-center, self-controlled clinical study with masked evaluation.
Eligible patients will receive 2 treatments on both upper arms (4-6 weeks apart) using the Sofwave System.
Treatment may be administered after the enrollment and screening at the first visit, or it may occur later following the enrollment and screening activities based on site scheduling availabilities. All patients will return to the clinic for follow up visit at 3 months ± 2 weeks post last treatment (FU1).
Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Upper Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sofwave | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of improvement of upper arms lax skin | following Sofwave treatment as evaluated by independent masked reviewers | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruthie Amir, MD | CMO | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laser & Skin Surgery Center of Northern California | Sacramento | California | 95816 | United States | ||
| Advanced Dermatology |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| D018232 | Rhabdomyosarcoma, Alveolar |
| 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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|
| Lincolnshire |
| Illinois |
| 60069 |
| United States |
| Laser & Skin Surgery Center of New York® | New York | New York | 10016 | United States |
| Main Line Center for Laser Surgery | Ardmore | Pennsylvania | 19003 | United States |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D012208 | Rhabdomyosarcoma |
| D009217 | Myosarcoma |
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D012509 | Sarcoma |