Fat Burn Clinical Trial
Official title:
Abdominal Treatment With Simultaneous Application of Noninvasive Repetitive Pulse Magnetic Stimulation (rPMS) and Radiofrequency
Verified date | March 2021 |
Source | BTL Industries Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the clinical efficacy and safety of a simultaneous treatment by repetitive pulse magnetic stimulation and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat. 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 three (3) treatment visits and two to three follow-up visits. All of the study subjects will receive the treatment with the subject device.
Status | Completed |
Enrollment | 41 |
Est. completion date | March 15, 2021 |
Est. primary completion date | June 9, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - Age = 21 years - Voluntarily signed 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 tumour - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Chicago Cosmetic Surgery and Dermatology | Chicago | Illinois |
United States | Skin Care Physicians of Georgia | Macon | Georgia |
Lead Sponsor | Collaborator |
---|---|
BTL Industries Ltd. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of change in adipose and muscular layer thickness between pre-treatment and post-treatment based on MRI scans | MRI will be conducted at the baseline visit and all follow-up visits. The imaging will be conducted at the same surface area each time.
Hospital-grade MRI device will be used to scan abdominal area of each subject. The MRI scan without any contrast agent will be performed, with the scanned body segment determined by vertebrae T12 and S1. Lateral cuts from 5 cm below the umbilicus and 5 cm above the umbilicus will be evaluated for the thickness of muscle and subcutaneous adipose tissue. |
4 months | |
Primary | Evaluation of change in adipose layer thickness between pre-treatment and post-treatment based on waist circumference measurements | Waist circumference measure will be conducted at the baseline visit, after last treatment and during follow-up visits.
The waist circumference measure will be made at the top of the subject's iliac crest, with the tape held snugly, but not constricting, and at a level parallel to the floor. For the measurement, a stretch-resistant tape will be used. During the measuring, subject will stand with arms at the side, feet positioned close together, and weight evenly distributed across the feet. The subject will be instructed to relax and take a few deep, natural breaths before the actual measurement is made. The subjects will be measured in underwear only, after voiding the bladder. |
4 months | |
Secondary | Evaluation of subject's satisfaction with the treatment using the Subject Satisfaction Questionnaire | The 5-point Likert scale Satisfaction questionnaire will be used to evaluate the participant's satisfaction with the therapy outcome with answer "Strongly agree" being the most positive outcome and "Strongly disagree" the most negative. Subject satisfaction will be assessed after the last therapy visit and during the follow-up visits. | 7 months | |
Secondary | Safety of the device measured via the occurrence of adverse events or lack thereof | The occurrence of adverse events will be followed throughout the whole study. | 7 months |
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