Fat Reduction and Muscle Toning of Thighs

BTL

Status: Completed

Conditions: Fat Burn

Treatments: Device: BTL-899

Study type: Interventional

Funder types: Industry

Identifiers

NCT04599257

BTL-703_300

Details and patient eligibility

About

This study will evaluate the clinical efficacy and safety of a simultaneous application of high-intensity focused electromagnetic procedure and radiofrequency energy for changes in subcutaneous fat tissue and muscle toning of thighs.

Enrollment: 93 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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93 participants in 1 patient group

Hip and thigh circumference changes

Experimental group

Description:

The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and two to three follow-up visits. All of the study subjects will receive the treatment with the subject device. At the baseline visit, MRI imaging will be performed; the subject's weight and hip and thigh circumference will be recorded. Photos of the treated area will be taken. The treatment administration phase will consist of four (4) treatments, delivered once a week. The applicator of the device will be applied over the treatment area. The device will induce visible muscle contractions along with heating of the subcutaneous fat. At the last therapy visit, the subject's weight and hip and thigh circumference will be recorded, and photos of the treated area will be taken. In addition, subjects will receive Subject Satisfaction Questionnaire to fill in.

Treatment:

Device: BTL-899