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This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive facial remodeling and investigate its effect on muscles and wrinkles.
The study is a single-center, single-arm, open-label, interventional study. The subjects will be enrolled and assigned into a single experimental study arm. The subjects will be required to complete four (4) treatment visits and two follow-up visits.
At the baseline visit health status will be assessed and, if needed, additional tests will be performed. Inclusion and exclusion criteria will be verified and informed consent will be signed.
The treatment administration phase consists of four (4) treatment visits, delivered 5-10 days apart.
Safety measures will include documentation of adverse events (AE) including the subject's experience of pain or discomfort after the procedure. Occurrence of AE's will be checked immediately after the first treatment visit, prior/post to every other procedure and at the follow-ups. Subjects will undergo two follow-up visits scheduled at 1 month and 3 months after the final treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BTL-785-7 Treatment | Experimental | Treatment with BTL-785F device (BTL-785-7 applicator) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTL-785-7 | Device | Treatment with the BTL-785F device with the BTL-785-7 applicator for improvement of the structure of facial muscles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Aesthetic Improvement of the Face | Three independent evaluators will review the photographs of treated areas for facial firming and lifting improvement (left and right cheeks and the forehead), and will provide an overall GAIS score. In other words, the reviewers will score the aesthetic improvement regarding the facial remodeling for the whole face. The GAIS is a clinically validated assessment tool used to assess overall aesthetic improvement such as facelift on a scale from -1 through 3, where the higher score is considered better. | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Therapy Comfort | The 7-point Likert scale Therapy Comfort questionnaire will be used for evaluating the comfort during the treatment sessions. Pain sensation will be rated by the subjects from 0 (no pain) to 10 (worst possible pain). | 5 months |
| Subject Satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yael Halaas, M.D., FACS | New York | New York | 10022 | 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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The 7-point Likert scale Subject Satisfaction Questionnaire will be used for evaluating the satisfaction. The Subject Satisfaction Questionnaire will be given to subjects after the last therapy, at 1-month and 3-month follow-up. The answers to the questions related to the subjects' overall skin and face appearance will vary from "strongly agree" to "strongly disagree". |
| 5 months |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |