Simultaneous Application of High-Intensity Focused Electromagnetic Procedure and Radiofrequency for Toning of Buttocks
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Muscle Tone
- Sponsor
- BTL Industries Ltd.
- Enrollment
- 67
- Locations
- 5
- Primary Endpoint
- The evaluation of change in adipose and muscle layer thickness.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This study will evaluate the clinical efficacy and safety of the BTL-899 device for toning of buttocks. The study is a prospective multi-center open-label two-arm study. The subjects will be enrolled and assigned into two study groups. The subjects will be enrolled and assigned into two study groups; HIFEM+RF (HR) and HIFEM (H) group. Subjects of both groups will be required to complete four (4) treatment visits and two follow-up visits.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \> 21 years
- •Voluntarily signed an informed consent form
- •BMI ≤ 35 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 affecting significant change in either direction during study participation
Exclusion Criteria
- •Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
- •Metal implants
- •Drug pumps
- •Malignant tumor
- •Pulmonary insufficiency
- •Injured or otherwise impaired muscles
- •Cardiovascular diseases
- •Disturbance of temperature or pain perception
- •Hemorrhagic conditions
- •Septic conditions and empyema
Outcomes
Primary Outcomes
The evaluation of change in adipose and muscle layer thickness.
Time Frame: 4 months
The evaluation of change in adipose and muscle layer thickness between pre-treatment and post-treatment based on hip circumference measurements.
The evaluation of change in structure of subcutaneous tissues between pre-treatment and post-treatment based on MRI imaging in both study groups.
Time Frame: 4 months
The evaluation of structural changes of subcutaneous tissues between pre-treatment and post-treatment based on MRI imaging through measurements of the thickness of subcutaneous tissues
Secondary Outcomes
- Patient's satisfaction with study treatment measured via questionnaires(4 months)
- Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire(4 months)