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Open-label, non-randomized, prospective, multi-center, self-controlled
Patients will receive 2 monthly treatments with the SofWave system and will be followed up twice: at 4 weeks and 12 weeks after last treatment (FU1-FU2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lift the upper lip and improve the peri-oral rhytids | 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 upper lip and peri-oral rhytids | Study will be considered a success if more than 50% of the subjects will have an improvement according to investigators' assessments of pre- and post Treatment 2D images | 12 weeks post last treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Premier Plastic Surgery | Palo Alto | California | 94306 | United States | ||
| Cosmetic Laser Dermatology |
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| ID | Term |
|---|---|
| C562489 | Lymphoid Interstitial Pneumonia |
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|
| San Diego |
| California |
| 92121 |
| United States |
| Advanced dermatoloy | Lincolnshire | Illinois | 60069 | United States |
| Aesthetic Revolution Las Vegas | Las Vegas | Nevada | 89148 | United States |
| New Jersey Plastic Surgeon | Montclair | New Jersey | 07042 | United States |
| UnionDerm | New York | New York | 10003 | United States |