Effect of the BTL-899 Therapy for Non-invasive Lipolysis and Circumference Reduction of Abdomen When Compared to a Sham Treatment
- Conditions
- Improvement of Abdomen Appearance
- Interventions
- Device: ShamDevice: BTL-899
- Registration Number
- NCT04000945
- Lead Sponsor
- BTL Industries Ltd.
- Brief Summary
The study is a prospective single-blinded two-arms study that includes three treatment procedures and four follow-up visits
- Detailed Description
This study will evaluate the clinical efficacy and safety of the BTL-899 device for non-invasive lipolysis and circumference reduction of abdomen. The study is a prospective single-blinded two-arms study. The subjects will be enrolled and assigned into a two study groups. All subjects will complete three (3) treatment visits and will be invited to four (4) follow-up visits 1, 2, 3 and 6-months after the final treatment. 6-months follow-up visit is the optional one.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- Age > 21 years
- Voluntarily signed informed consent form
- BMI ā¤ 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 his/her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation
- Cardiac pacemakers
- Cardiovascular diseases
- Implanted defibrillators, implanted neurostimulators
- Electronic implants
- Disturbance of temperature or pain perception
- Pulmonary insufficiency
- Metal implants
- Drug pumps
- Malignant tumor
- Hemorrhagic conditions
- Septic conditions and empyema
- Acute inflammations
- Systemic or local infection such as osteomyelitis and tuberculosis
- Contageous skin disease
- Elevated body temperature
- Pregnancy
- Breastfeeding
- Injured or otherwise impaired muscles
- Scars, open lesions and wounds at the treatment area
- Basedow's disease
- Previous liposuction in the treatment area in the last six months
- Abdominal wall diastasis
- Unstable weight within the last 6 months
- Previous body contouring treatments in the abdomen area in the last three months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham Arm Sham - BTL-899 Therapy Arm BTL-899 -
- Primary Outcome Measures
Name Time Method Occurrence of adverse events 7 months The occurrence of adverse events will be followed throughout the whole study.
Efficacy of the BTL-899 treatment for change in abdominal circumference 4 months Comparison of change in abdominal circumference at the final follow-up visit between two study groups.
- Secondary Outcome Measures
Name Time Method Efficacy of BTL-899 treatment for abdominal fat and circumference reduction, as assessed by two blinded evaluators 4 months Evaluation of aesthetic improvement achieved by abdominal fat and circumference reduction using photographs before and after the treatment.
Efficacy of the BTL-899 treatment for change in abdominal circumference 4 months Comparison of change in abdominal circumference at all study visits after the first therapy between two study groups.
Efficacy of the BTL-899 treatment for abdominal fat reduction 4 months Comparison of fat reduction between two study groups using ultrasound images.
Subject's satisfaction with study treatment 4 months Subject's satisfaction with the therapy results evaluated through the Subject Satisfaction Questionnaire (5-point scale).
Therapy comfort during the study treatment. 1 month Therapy comfort during the treatment evaluated through the Therapy Comfort Questionnaire (10-point scale).
Trial Locations
- Locations (1)
Dr-Denkova Dermatology
š§š¬Sofia, Bulgaria