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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 ± 2 weeks apart) on either one side (right or left) or both sides of the lateral/posterior upper thigh and/or buttocks using SofWave System with the Form applicator ('2X').
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 visit at 3 months ± 1 week 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 |
|---|---|---|---|
| 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. Other Names: SUPERB |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome Measure: | 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 | ||
| Schweiger Dermatology GP Research |
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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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| Hackensack |
| New Jersey |
| 07601 |
| United States |
| UnionDerm | New York | New York | 10003 | United States |
| Main Line Center for Laser Surgery | Ardmore | Pennsylvania | 19003 | United States |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | 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 |