Fat Burn
Conditions
Keywords
muscle strengthening, muscle tone, fat reduction
Brief summary
This study will evaluate the clinical efficacy and safety of a simultaneous application of high-intensity focused electromagnetic procedure and radiofrequency energy for changes in subcutaneous fat tissue and muscle toning of thighs.
Interventions
DEVICEBTL-899
The device applicator combines high-intensity focused electromagnetic procedure and radiofrequency energy to induce visible muscle contractions along with heating of the subcutaneous fat.
Sponsors
BTL Industries Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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 * Acute inflammations * Systemic or local infection such as osteomyelitis and tuberculosis * Contagious skin disease * Elevated body temperature * Pregnancy, postpartum period, nursing, and menstruation * Intrauterine device (IUD) * Swollen or neoplastic tissues, space-occupying lesions or skin eruptions in the treatment area * Basedow's disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of structural changes of subcutaneous tissues between pre-treatment and post-treatment based on MRI imaging | 7 months | The primary objective of the study is to determine the effectiveness of a simultaneous application of high-intensity focused electromagnetic procedure and radiofrequency energy for change in the adipose layer thickness between pre-treatment and post-treatment based on MRI imaging. The changes will be considered statistically significant where p-value \<0.05. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess subjects' satisfaction with the treatment using Subject Satisfaction Questionnaire | 7 months | The 5-point Likert scale Satisfaction questionnaire will be used to evaluate the participant's satisfaction with the therapy outcome. Subject satisfaction will be assessed after the last therapy visit and during the follow-up visits with 4-therapy related questions with answer Strongly agree will be the best possible answer and Strongly disagree the worst. |
| Assess safety profile by recording of adverse events | 7 months | All AEs including local and systemic reactions not meeting the criteria for serious adverse events will be captured on the appropriate CRF. Information to be collected includes event description, time of onset, clinician's assessment of severity, relationship to study product (assessed only by those with the training and authority to make a diagnosis, which would include MD, DDS, DMD, PA, Nurse Practitioner or DO), and time of resolution/stabilization of the event. All AEs occurring during the study must be documented appropriately regardless of relationship to study device. All AEs will be followed to adequate resolution. |
Countries
United States
Outcome results
None listed