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

BTL

Status

Completed

Conditions

Muscle Tone Increased

Treatments

Device: High-Intensity Focused Electromagnetic (HIFEM) Field Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT03815747

BTL-799-MRI

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

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