NCT03758690CompletedNot Applicable
Efficacy of Abdominal Treatment With High-Intensity Focused Electromagnetic (HIFEM) Field Device in Women After Childbirth
BTL Industries Ltd.4 sites in 1 country10 target enrollmentStarted: October 25, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 4
- Primary Endpoint
- Effectiveness of the device for abdominal toning according to MRI images
Study Overview
Brief Summary
Evaluation of use of the High-Intensity Focused Electromagnetic (HIFEM) Field Device in women after childbirth.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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
- •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
Outcomes
Primary Outcomes
Effectiveness of the device for abdominal toning according to MRI images
Time Frame: 7 months
Evaluation of MRI images before and after the therapy procedure.
Effectiveness of the device for abdominal toning according to waist circumference measurements
Time Frame: 7 months
Evaluation of waist circumference measurements (in centimeters).
Secondary Outcomes
- Subject's satisfaction with study treatment: Questionnaire(7 months)
- Determination of side effects and adverse events (AE) associated with the study device.(7 months)
Investigators
Study Sites (4)
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