High-Intensity Focused Electromagnetic (HIFEM) Field Device in Women After Childbirth
Not Applicable
Completed
- Conditions
- Muscle Tone Increased
- Interventions
- Device: High-Intensity Focused Electromagnetic (HIFEM) Field Device
- Registration Number
- NCT03758690
- Lead Sponsor
- BTL Industries Ltd.
- Brief Summary
Evaluation of use of the High-Intensity Focused Electromagnetic (HIFEM) Field Device in women after childbirth.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 10
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Group High-Intensity Focused Electromagnetic (HIFEM) Field Device Treatment with the investigational device - High-Intensity Focused Electromagnetic (HIFEM) Field Device
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
Chicago Cosmetic Surgery and Dermatology
🇺🇸Chicago, Illinois, United States
Skin Care Physicians of Georgia
🇺🇸Macon, Georgia, United States