Status:
COMPLETED
MRI Evaluation of Change in Gluteal Muscles Following the Treatment With HIFEM Device
Lead Sponsor:
BTL Industries Ltd.
Conditions:
Muscle Tone Increased
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
This study will use magnetic resonance imaging (MRI) to evaluate changes in gluteal muscle following the treatment with HIFEM stimulation for aesthetic improvement of buttocks.
Eligibility Criteria
Inclusion
- Age ≥ 21 years
- 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 his/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
- 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
Key Trial Info
Start Date :
January 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 27 2020
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03815747
Start Date
January 11 2019
End Date
January 27 2020
Last Update
May 20 2020
Active Locations (1)
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1
Art of Skin MD
Solana Beach, California, United States, 92075