Non-invasive Lipolysis on Human Thighs and Saddlebags

Study Overview
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Brief Summary
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The study is a prospective two-arm, open-label, interventional study with four treatment procedures and two follow-up visits.

Detailed Description
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This study aims to evaluate the clinical safety and efficacy of the BTL-899 device for non-invasive lipolysis and fat reduction in the thigh and saddlebag area. This is a prospective, open-label, two-arm study; therefore the participants will be assigned to two study groups. Each participant will complete 4 treatment visits and 2 follow-up visits.

Official Title
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Effect on BTL-899 Device for Non-invasive Lipolysis on Human Thighs and Saddlebags

Conditions
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Adipose Tissue Reduction

Intervention / Treatment
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* Device: BTL-899


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body Mass Index (BMI) of 20 to 35 kg/m2. Visible excess of adipose tissue at the treatment sites (ARM 1 - thigh area; ARM 2 - saddlebags area). Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring and/or weight loss during study participation. No procedure for fat reduction (including cellulite treatment) in the last six months. Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting a significant change of weight in either direction during study participation. Age between 21 and 70 years. Exclusion Criteria: Electronic implants (such as intrauterine device, cardiac pacemakers, defibrillators, and neurostimulators) Cardiovascular diseases Vascular diseases (such as chronic venous insufficiency, deep venous thrombosis, varicose veins, etc.) Femoral or inguinal hernia 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 Unstable weight within the last 6 months (change in weight ± 3%) Previous body contouring or cellulite treatments in the thighs area in the last six months Any other disease or condition at the investigator's discretion

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thighs circumference reduction<br>The subjects will be enrolled and treated once per week. Both legs will be treated consecutively. The therapy will be applied simultaneously. | Device: BTL-899<br>* Treatment with study device.<br>|
| Experimental: Saddlebags fat thickness reduction<br>The subjects will be enrolled and treated once per week. Both legs will be treated consecutively. The therapy will be applied consecutively too. | Device: BTL-899<br>* Treatment with study device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Fat Thickness Measured via Ultrasound | To gather clinical evidence that the BTL-899 device is able to induce non-invasive lipolysis when used on thighs and saddlebags. The fat thickness changes will be measured by means of ultrasound. | 6 months | 
| Participants' Satisfaction Measured Via Questionnaires | Evaluation of the participants' satisfaction with the therapy via Therapy Satisfaction Questionnaires. Global Aesthetic Improvement Scale (Quality of Life questionnaire) will be used where score 3 means very much improved and -3 is very much worse. | 6 months | 
| Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire | The outcome will further be measured through the occurrence of adverse events or lack thereof. On Numerical Analog Scale (0-10), where 0 represents 'no pain' and 10 represents 'worst possible pain' select the level of pain experienced during the treatment. | 6 months |