MRI Evaluation of Change in Gluteal Muscles Following the Treatment With HIFEM Device



Status:Recruiting
Healthy:No
Age Range:21 - Any
Updated:1/30/2019
Start Date:January 11, 2019
End Date:December 31, 2019

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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.


Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
1
site
437 Highway 101
Solana Beach, California 92075
Phone: 858-792-7546
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mi
from
Solana Beach, CA
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