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This study will evaluate the clinical efficacy and safety of the BTL-899 device for toning of buttocks. The study is a prospective multi-center open-label two-arm study. The subjects will be enrolled and assigned into two study groups. The subjects will be enrolled and assigned into two study groups; HIFEM+RF (HR) and HIFEM (H) group. Subjects of both groups will be required to complete four (4) treatment visits and two follow-up visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIFEM+RF (HR) | Experimental | The HR group will receive treatment with intensities of a magnetic field and radiofrequency energy just below the patient's tolerance threshold. The device will induce visible muscle contractions along with mild heating of the muscles. |
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| HIFEM (H) | Experimental | The H group will receive a treatment with the intensities of the magnetic field just below the patient's tolerance threshold without the use of radiofrequency. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTL-899 Buttocks | Device | The treatment administration phase in both study groups will consist of four (4) treatments, delivered 5-10 days apart. The applicators of BTL-899 will be applied over the gluteal area. |
| Measure | Description | Time Frame |
|---|---|---|
| The evaluation of change in structure of subcutaneous tissues between pre-treatment and post-treatment based on MRI imaging in both study groups. | The evaluation of structural changes of subcutaneous tissues between pre-treatment and post-treatment based on MRI imaging through measurements of the thickness of subcutaneous tissues | 4 months |
| The evaluation of change in adipose and muscle layer thickness. | The evaluation of change in adipose and muscle layer thickness between pre-treatment and post-treatment based on hip circumference measurements. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's satisfaction with study treatment measured via questionnaires | To determine the patient's satisfaction with study treatment. The 5-point Likert scale Satisfaction questionnaire will be used to evaluate the participant's satisfaction with the therapy outcome. Subject satisfaction will be assessed after the last therapy visit and during the follow-up visits with 4therapy-related questions, where the answer "Strongly agree" will be the best possible answer and "Strongly disagree" the worst. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Georgi Petkov | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contour Medical | Gilbert | Arizona | 85297 | United States | ||
| Skin Laser and Surgery Specialist, a Division of Schweiger Dermatology |
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The subjects will be enrolled and assigned into two study groups; HIFEM+RF (HR) and HIFEM (H) group. Subjects of both groups will be required to complete four (4) treatment visits and two follow-up visits. All of the study subjects will receive the treatment with the subject device.
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| 4 months |
| Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire | On Numerical Analog Scale (0-10), where 0 represents 'no pain' and 10 represents 'worst possible pain' select the level of pain experienced during the treatment. The outcome will further be measured through the occurrence of adverse events or lack thereof. | 4 months |
| Hackensack |
| New Jersey |
| 07601 |
| United States |
| New Jersey Plastic Surgery (NJPS) | Montclair | New Jersey | 07042 | United States |
| JUVA Skin & Laser Center | New York | New York | 10022 | United States |
| Refresh Dermatology | Houston | Texas | 77081 | United States |