High-Intensity Focused Electromagnetic (HIFEM) Field Device in Women After Childbirth

Study Overview
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Brief Summary
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Evaluation of use of the High-Intensity Focused Electromagnetic (HIFEM) Field Device in women after childbirth.

Official Title
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Efficacy of Abdominal Treatment With High-Intensity Focused Electromagnetic (HIFEM) Field Device in Women After Childbirth

Conditions
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Muscle Tone Increased

Intervention / Treatment
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* Device: High-Intensity Focused Electromagnetic (HIFEM) Field Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-breastfeeding women 3-36 months after childbirth Voluntarily signed informed consent form BMI ≤ 30 kg/m2 Women of child-bearing potential are required to use birth control measures during the whole duration of the study Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation Subjects willing and able to maintain her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation Exclusion Criteria: Cardiac pacemakers Implanted defibrillators, implanted neurostimulators Electronic implants Pulmonary insufficiency Metal implants Drug pumps Application in the head area Application in the heart area Malignant tumor Fever Pregnancy Breastfeeding Following recent surgical procedures when muscle contraction may disrupt the healing process Application over areas of the skin which lack normal sensation Scars, open lesions and wounds at the treatment area Unrepaired abdominal hernia Patients after Cesarean section delivery

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Treatment with the investigational device - High-Intensity Focused Electromagnetic (HIFEM) Field Device | Device: High-Intensity Focused Electromagnetic (HIFEM) Field Device<br>* The High-Intensity Focused Electromagnetic (HIFEM) Field device will be applied.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |