High-Intensity Focused Electromagnetic Procedure and Radiofrequency for Toning of Buttocks
Completed · Not applicable
Conditions studied: Muscle Tone
In brief
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.
Key facts
- Study ID
- NCT04871503
- Run by
- BTL Industries Ltd.
- People needed
- 67
- Starts
- 2021-03-01
- Expected to finish
- 2022-01-12
- Last updated by the study team
- 2022-02-09
Who can join
Age: 21 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
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
- Contour Medical — Gilbert, Arizona, United States
- Skin Laser and Surgery Specialist, a Division of Schweiger Dermatology — Hackensack, New Jersey, United States
- New Jersey Plastic Surgery (NJPS) — Montclair, New Jersey, United States
- JUVA Skin & Laser Center — New York, New York, United States
- Refresh Dermatology — Houston, Texas, United States
Full record on ClinicalTrials.gov
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