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

Completed · Not applicable

Conditions studied: Muscle Tone Increased

In brief

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

Key facts

Study ID: NCT03758690
Run by: BTL Industries Ltd.
People needed: 10
Starts: 2018-10-25
Expected to finish: 2020-01-02
Last updated by the study team: 2020-05-27

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Skin Care Physicians of Georgia — Macon, Georgia, United States
Chicago Cosmetic Surgery and Dermatology — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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