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

Completed · Not applicable

Conditions studied: Muscle Tone Increased

In brief

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.

Key facts

Study ID

NCT03815747

Run by

BTL Industries Ltd.

People needed

7

Starts

2019-01-11

Expected to finish

2020-01-27

Last updated by the study team

2020-05-20

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Art of Skin MD — Solana Beach, California, United States

Full record on ClinicalTrials.gov

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