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)
Loading locations...
Similar Trials
Not yet recruiting
Not Applicable
Effectiveness of High Intensity Electromagnetic Therapy and Pelvic Floor Exercises in Women With Urinary IncontinenceUrinary IncontinenceNCT06450795Istanbul Medipol University Hospital40
Completed
Not Applicable
Effects of High Intensity Focused Electromagnetic Therapy With Pelvic Floor Muscle Training on Urine Leakage and Quality of Life in Primipara or Multipara Women With Stress Urinary IncontinenceStress Urinary IncontinenceNCT06638489Hong Kong Metropolitan University40
Recruiting
Not Applicable
Effect of High Intensity Electromagnetic Body Shaping on Profile of Metabolism in Obese MenCentral ObesityNCT06024018Cairo University60
Recruiting
Not Applicable
The Effect of High-Intensity Focused Electromagnetic on Urinary Incontinence SymptomsUrinary Incontinence, Stress IncontinenceNCT05693103Kaohsiung Medical University Chung-Ho Memorial Hospital30
Completed
Not Applicable
High Intensity Focused Electromagnetic Field Device for Urinary IncontinenceUrge IncontinenceUrge and StressOveractive BladderStress Urinary IncontinenceNCT04031014Boston Urogynecology Associates36
