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Open-label, non-randomized, prospective, multi-center, self-controlled clinical study with masked evaluation.
Eligible patients will receive 2 treatments (4-6 weeks apart) on one side (right or left) of the lateral/ posterior upper thigh / buttocks using 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 one follow up visits at 3 months ± 3 weeks post last treatment (FU1). Optionally, additional follow-up visit will be conducted 6 (± 4 weeks) months following end of treatment (FU2).
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 |
|---|---|---|---|
| Cellulite | 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 in the appearance of cellulite on the upper thigh/buttock area | following Sofwave treatments based on 6 points simplified Cellulite Severity Scale (CSS), 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 |
|---|---|---|---|---|---|---|
| Laser & Skin Surgery Center of Northern California | Sacramento | California | 95816 | United States | ||
| UnionDerm |
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| ID | Term |
|---|---|
| D000071697 | Cellulite |
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012873 | Skin Diseases, Genetic |
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|
| New York |
| New York |
| 10003 |
| United States |
| Laser & Skin Surgery Center of New York® | New York | New York | 10016 | United States |
| Dermatology, Laser & Vein Specialists of the Carolinas | Charlotte | North Carolina | 28207 | United States |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |