Effect of the BTL-899 Therapy for Non-invasive Lipolysis and Circumference Reduction of Abdomen

Study Overview
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Brief Summary
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The study is a prospective open-label single-arm 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 open-label single-arm study. The subjects will be enrolled and assigned into a single study group. 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

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 ≥ 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BTL-899 Therapy Arm<br>BTL-899 therapy, 3 therapies | Device: BTL-899<br>* BTL-899<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 abdomen circumference reduction after the final follow-up visit | Evaluation of change in abdomen circumference using tape measurements in cm at the final follow-up visit. | 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 fat and circumference reduction in abdomen, as assessed by two blinded evaluators | Evaluation of photographs before and after the treatment. | 4 months | 
| Efficacy of the BTL-899 treatment for abdomen circumference reduction | Evaluation of change in abdomen circumference using tape measurements in cm at all study visits after the first therapy. | 4 months | 
| Ultrasound imaging | Evaluation of 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 |