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This study will use magnetic resonance imaging (MRI) to evaluate changes in gluteal muscle following the treatment with HIFEM stimulation for aesthetic improvement of buttocks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Experimental | Treatment with the investigational device - High- Intensity Focused Electromagnetic (HIFEM) Field Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Intensity Focused Electromagnetic (HIFEM) Field Device | Device | The High-Intensity Focused Electromagnetic (HIFEM) Field device will be applied. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of the device for toning of buttocks according to MRI images | Evaluation of change in MRI images before and after the therapy procedure. | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Subject's satisfaction with study treatment | Subject's satisfaction with the therapy results evaluated through the Subject Satisfaction Questionnaire. The 7-point Likert scale Subject Satisfaction Questionnaire will be used for an analysis of the subject's opinion of the therapy results. | 7 months |
| Side effects and adverse events (AE) associated with the study device |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Art of Skin MD | Solana Beach | California | 92075 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 10, 2020 | Oct 1, 2020 | 3 | ||
| Oct 13, 2020 |
| ID | Term |
|---|---|
| D009122 | Muscle Hypertonia |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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The occurrence of side effects and adverse events will be followed throughout the whole study |
| 7 months |
| Nov 3, 2020 |
| 4 |
| Jan 28, 2021 | Feb 15, 2021 | 5 |
| D013568 | Pathological Conditions, Signs and Symptoms |