Fat Burn Clinical Trial
Official title:
Simultaneous Application of High-Intensity Focused Electromagnetic Procedure and Radiofrequency for Non-invasive Lipolysis and Improvement of Muscle Tone in Lateral Abdomen
Verified date | April 2024 |
Source | BTL Industries Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the clinical efficacy and performance of the BTL-899 device for changes in subcutaneous fat and muscle tissue in the lateral abdomen region (also referred to as flanks or "love handles"). The study is a prospective, multi-center, open-label, single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and two follow-up visits. All of the study subjects will receive the treatment with the subject device.
Status | Completed |
Enrollment | 46 |
Est. completion date | October 11, 2023 |
Est. primary completion date | January 10, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 22 Years and older |
Eligibility | Inclusion Criteria: - Age 22 years and older - 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 their 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 - A metal-containing intrauterine device (IUD) - Swollen or neoplastic tissues, space-occupying lesions or skin eruptions in the treatment area - Graves' disease |
Country | Name | City | State |
---|---|---|---|
United States | Chicago Cosmetic Surgery and Dermatology | Chicago | Illinois |
United States | AboutSkin Research, LLC | Greenwood Village | Colorado |
United States | Georgia Plastic & Reconstructive Surgery | Marietta | Georgia |
United States | New Jersey Plastic Surgery (NJPS) | Montclair | New Jersey |
United States | Laser & Skin Surgery Center of Northern California | Sacramento | California |
United States | Integrated Aesthetics | Spring | Texas |
Lead Sponsor | Collaborator |
---|---|
BTL Industries Ltd. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of change in adipose and muscle layer thickness | The changes in muscles and adipose tissue of the treatment area between pre-treatment and post-treatment will be evaluated according to the MRI imaging and waist circumference measurements.
Using the obtained MRI images, changes in adipose and muscular tissues before and after the therapy sessions will be compared for every participant according to the study phase. The circumference before and after the study therapy will be compared for each subject, according to the study phase. The circumference will be measured to identify any change in abdominal circumference related to changes in adipose tissue and muscle thickness. When applicable, the statistical analysis will be conducted in Microsoft Excel spreadsheet software with a level of significance set to 5%. |
4 months | |
Secondary | Subject Satisfaction | The 5-point Likert scale Subject Satisfaction Questionnaire will be used for an analysis of the subject's opinion of the therapy results, where the best possible answer would be "strongly agree" and the worst "strongly disagree". | 4 months |
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