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It was not possible to recruit any patients at that time.
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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. Subjects will receive Buttocks Evaluation Questionnaire to fill in.
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, Buttocks Evaluation and Therapy Comfort Questionnaires 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 and buttocks evaluation will be noted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Treatment with the investigational device BTL EMSCULPT. |
|
| 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 |
|---|---|---|
| Subject's satisfaction | 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. | 13 months |
| Effectiveness of the device assessed through Buttocks Evaluation Questionnaire | The 7 point Likert scale Buttocks Evaluation Questionnaire will be used for an assessment if there is a change in subject's perception of their own buttocks area before and after the therapy session. The total possible score ranges from 4 points (lowest possible satisfaction) to 28 points (highest possible satisfaction). | 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of treatment-related adverse events | The secondary objective of the study is to determine side effects and adverse events (AE) associated with the treatment of the abdominal area. The occurrence of adverse events will be followed throughout the whole study. | 13 months |
| Therapy comfort |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contour Medical | Gilbert | Arizona | 85297 | United States | ||
| Plastic Surgery Excellence |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Therapy comfort will be noted at the last therapy visit. Subjects will be asked to evaluate the agreement with the statement concerning the conformity of the study treatment. Subjects will be evaluating the agreement by choosing an answer on a scale between 1 (Strongly disagree) and 5 (Strongly agree). Based on a given answers, the therapy comfort will be calculated. |
| 3 months |
| Beverly Hills |
| California |
| 90212 |
| United States |
| Dr. Mariano Busso Aesthetic Dermatology | Miami | Florida | 33133 | United States |
| Chicago Cosmetic Surgery and Dermatology | Chicago | Illinois | 60654 | United States |
| Ovation Med Spa | Houston | Texas | 77056 | United States |
| Refresh Dermatology | Houston | Texas | 77401 | United States |
| Aesthe Clinic | Sofia | 1000 | Bulgaria |