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It wasn't possible to recruit the desired number of patients.
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This study will evaluate the clinical safety and patient satisfaction with the high power magnet system for the aesthetic improvement of buttocks. The study is a prospective multi-center open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and three follow-up visits - 1 month, 3 months and 12 months after the final treatment. Study will be conducted at several study sites.
At the baseline visit, subject's weight will be recorded.
The treatment administration phase will consist of four (4) treatments, delivered twice a week. The applicator will be applied over the gluteal area. Visible contractions will be induced by the device.
At the last therapy visit, the subject's weight will be recorded. In addition, subjects will receive Subject Satisfaction Questionnaire to fill in.
Safety measures will include documentation of adverse events (AE) including subject's experience of pain or discomfort after the procedure. Following each treatment administration and at the follow-up visits, subjects will be checked for immediate post-procedure adverse event assessment.
Post-procedure evaluation (follow-up visits) will be conducted 1 month, 3 months and 12 months after the final treatment. A weight measure will be conducted. Also, subject's satisfaction will be noted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Treatment with the investigational device BTL EMSCULPT. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment with BTL EMSCULPT device. | Device | The treatment administration phase will consist of four (4) treatments, delivered twice a week. The applicator will be applied over the buttock area. Visible contractions will be induced by the device. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's satisfaction with study treatment for non-invasive aesthetic improvement of buttocks. | Subject's satisfaction with the therapy results evaluated through the Subject Satisfaction Questionnaire. The 5-point Likert scale Subject Satisfaction Questionnaire will be used for an analysis of the subject's opinion of the therapy results. Subjects will be evaluating agreement with three different statements (concerning satisfaction with therapy results and appearance of abdominal area after therapy) by choosing an answer on a scale between 1 (Strongly disagree) and 5 (Strongly agree). Minimally 80% of the treated subjects should report the agreement with all three statements given in the questionnaire (answers "Agree" and "Strongly agree") in order to claim subject's satisfaction with the therapy outcome. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Determining side effects and adverse events (AE) associated with the treatment of the gluteal area. | The occurrence of adverse events throughout the whole study. | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Mariano Busso Aesthetic Dermatology | Miami | Florida | 33133 | United States | ||
| Aesthe Clinic |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Sofia |
| 1000 |
| Bulgaria |