Status:
COMPLETED
High-Intensity Focused Electromagnetic Procedure and Radiofrequency for Toning of Buttocks
Lead Sponsor:
BTL Industries Ltd.
Conditions:
Muscle Tone
Eligibility:
All Genders
21-70 years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 12 2022
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT04871503
Start Date
March 1 2021
End Date
January 12 2022
Last Update
February 9 2022
Active Locations (5)
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1
Contour Medical
Gilbert, Arizona, United States, 85297
2
Skin Laser and Surgery Specialist, a Division of Schweiger Dermatology
Hackensack, New Jersey, United States, 07601
3
New Jersey Plastic Surgery (NJPS)
Montclair, New Jersey, United States, 07042
4
JUVA Skin & Laser Center
New York, New York, United States, 10022