Muscle Tone Increased
Conditions
Brief summary
Evaluation of use of the High-Intensity Focused Electromagnetic (HIFEM) Field Device in women after childbirth.
Interventions
The High-Intensity Focused Electromagnetic (HIFEM) Field device will be applied.
Sponsors
BTL Industries Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of the device for abdominal toning according to MRI images | 7 months | Evaluation of MRI images before and after the therapy procedure. |
| Effectiveness of the device for abdominal toning according to waist circumference measurements | 7 months | Evaluation of waist circumference measurements (in centimeters). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject's satisfaction with study treatment: Questionnaire | 7 months | 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. |
| Determination of side effects and adverse events (AE) associated with the study device. | 7 months | The occurrence of side effects and adverse events will be followed throughout the whole study |
Countries
United States
Outcome results
None listed