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Evaluation of use of the High-Intensity Focused Electromagnetic (HIFEM) Field Device in women after childbirth.
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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 abdominal toning according to MRI images | Evaluation of MRI images before and after the therapy procedure. | 7 months |
| Effectiveness of the device for abdominal toning according to waist circumference measurements | Evaluation of waist circumference measurements (in centimeters). | 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Subject's satisfaction with study treatment: Questionnaire | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin Care Physicians of Georgia | Macon | Georgia | 31217 | United States | ||
| Chicago Cosmetic Surgery and Dermatology |
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| 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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| Determination of side effects and adverse events (AE) associated with the study device. |
The occurrence of side effects and adverse events will be followed throughout the whole study |
| 7 months |
| Chicago |
| Illinois |
| 60654 |
| United States |
| D013568 | Pathological Conditions, Signs and Symptoms |