Status:
COMPLETED
High-Intensity Focused Electromagnetic (HIFEM) Field Device in Women After Childbirth
Lead Sponsor:
BTL Industries Ltd.
Conditions:
Muscle Tone Increased
Eligibility:
FEMALE
21+ years
Phase:
NA
Brief Summary
Evaluation of use of the High-Intensity Focused Electromagnetic (HIFEM) Field Device in women after childbirth.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 2 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03758690
Start Date
October 25 2018
End Date
January 2 2020
Last Update
May 27 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Skin Care Physicians of Georgia
Macon, Georgia, United States, 31217
2
Chicago Cosmetic Surgery and Dermatology
Chicago, Illinois, United States, 60654