Clinical trial NCT04871503: High-Intensity Focused Electromagnetic Procedure and Radiofrequency for Toning of Buttocks
Official title: Simultaneous Application of High-Intensity Focused Electromagnetic Procedure and Radiofrequency for Toning of Buttocks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscle Tone
Lead sponsor: BTL Industries Ltd.
Sponsor class: INDUSTRY
First posted: 2021-05-04
Enrollment: 67
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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. All of the study subjects will receive the treatment with the subject device.
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion Criteria:

* 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 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
* Intrauterine device (IUD)
* Swollen or neoplastic tissues, space-occupying lesions or skin eruptions in the treatment area
* Basedow's disease

Primary outcomes:
measure: The evaluation of change in structure of subcutaneous tissues between pre-treatment and post-treatment based on MRI imaging in both study groups.
timeFrame: 4 months
measure: The evaluation of change in adipose and muscle layer thickness.
timeFrame: 4 months
Secondary outcomes:
measure: Patient's satisfaction with study treatment measured via questionnaires
timeFrame: 4 months
measure: Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire
timeFrame: 4 months
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Contour Medical
state: Arizona
city: Hackensack
country: United States
facility: Skin Laser and Surgery Specialist, a Division of Schweiger Dermatology
state: New Jersey
city: Montclair
country: United States
facility: New Jersey Plastic Surgery (NJPS)
state: New Jersey
city: New York
country: United States
facility: JUVA Skin & Laser Center
state: New York
city: Houston
country: United States
facility: Refresh Dermatology
state: Texas
Study officials:
affiliation: Sponsor GmbH
name: Georgi Petkov
role: STUDY_DIRECTOR
References: