Clinical Evaluation of the BTL-899 Device for Non-invasive Lipolysis on Human Fat Tissue

Study Overview
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Brief Summary
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The subjects will be enrolled and assigned to a single study group. They will be required to complete two treatment visits and come for a biopsy procedure.

Official Title
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Clinical Evaluation of the BTL-899 Device for Non-invasive Lipolysis on Human Fat Tissue

Conditions
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Improvement of Abdomen Appearance

Intervention / Treatment
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* Device: BTL-899


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age above 21 years and below 60 years Voluntarily signing of the informed consent form Women of child-bearing potential are required to use birth control measures during the whole duration of the study Eligibility to fat tissue biopsy at surgeon discretion, incl. at least 3-4 cm pinchable fat in the abdominal area Subjects willing and able to abstain from partaking in any 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: Electronic implants (such as cardiac pacemakers, defibrillators and neurostimulators) Cardiovascular diseases 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 Contagious 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 (change in weight ± 3%) Previous body contouring treatments in the abdomen area in the last three months Any disease or condition contradicting the fat tissue biopsy at the surgeon discretion Any disease or condition that may compromise the histologic observation at the pathologist discretion

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BTL-899 Therapy Arm<br> | Device: BTL-899<br>* BTL-899 therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histology Examination | Histological examination of the fat tissue after BTL-899 treatment at various days after the procedure | 4 months | 
| Evaluation of Satefy: Occurence of adverse events throughout the study | Following the occurence of adverse events throughout the study. | 4 months |