Effect of the BTL-899 Therapy for Non-invasive Lipolysis and Circumference Reduction of Abdomen When Compared to a Sham Treatment

Study Overview
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Brief Summary
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The study is a prospective single-blinded two-arms study that includes three treatment procedures and four follow-up visits

Detailed Description
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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.

Official Title
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Evaluation of Safety and Efficacy of the BTL-899 Device for Non-invasive Lipolysis and Circumference Reduction of Abdomen When Compared to a Sham Treatment

Conditions
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Improvement of Abdomen Appearance

Intervention / Treatment
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* Device: BTL-899
* Device: Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 21 years Voluntarily signed 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 his/her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BTL-899 Therapy Arm<br> | Device: BTL-899<br>* Treatment with BTL-899 device, 3 therapies<br>|
| Sham Comparator: Sham Arm<br> | Device: Sham<br>* Sham treatment with BTL-899 device, 3 visits<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of the BTL-899 treatment for change in abdominal circumference | Comparison of change in abdominal circumference at the final follow-up visit between two study groups. | 4 months | 
| Occurrence of adverse events | The occurrence of adverse events will be followed throughout the whole study. | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of BTL-899 treatment for abdominal fat and circumference reduction, as assessed by two blinded evaluators | Evaluation of aesthetic improvement achieved by abdominal fat and circumference reduction using photographs before and after the treatment. | 4 months | 
| Efficacy of the BTL-899 treatment for change in abdominal circumference | Comparison of change in abdominal circumference at all study visits after the first therapy between two study groups. | 4 months | 
| Efficacy of the BTL-899 treatment for abdominal fat reduction | Comparison of fat reduction between two study groups using ultrasound images. | 4 months | 
| Subject's satisfaction with study treatment | Subject's satisfaction with the therapy results evaluated through the Subject Satisfaction Questionnaire (5-point scale). | 4 months | 
| Therapy comfort during the study treatment. | Therapy comfort during the treatment evaluated through the Therapy Comfort Questionnaire (10-point scale). | 1 month |