rPMS and Radiofrequency for Abdominal Toning and Reduction of Subcutaneous Fat
Completed · Not applicable · Has a placebo group
Conditions studied: Fat Burn
In brief
This study will evaluate the clinical efficacy and safety of a simultaneous treatment by high power magnet and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat. The study is a prospective multi-center single-blinded sham-controlled study. The subjects will be enrolled and assigned into two study groups; active and sham group. Subjects of both groups will be required to complete three (3) treatment visits and two to three follow-up visits.
Key facts
- Study ID
- NCT04587986
- Run by
- BTL Industries Ltd.
- People needed
- 67
- Starts
- 2019-07-30
- Expected to finish
- 2021-03-16
- Last updated by the study team
- 2021-04-01
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Julene B. Samuels — River Bluff, Kentucky, United States
- Maryland Laser Skin and Vein Institute — Hunt Valley, Maryland, United States
- JUVA Skin & Laser Center — New York, New York, United States
Full record on ClinicalTrials.gov
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