Safety and Efficacy of the BTL-703 Treatment for the Non-invasive Lipolysis

Study Overview
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Brief Summary
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The study will evaluate safety and efficacy of the BTL-703 device for the non-invasive lipolysis.

Official Title
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Safety and Efficacy of the BTL-703 Treatment for the Non-invasive Lipolysis

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Device: BTL-703 (Treatment group)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 22 years Voluntarily signed informed consent form Exclusion Criteria: Implanted electronic device such as a cardiac pacemaker, bladder stimulator, spinal cord stimulator or electrodes for a myoelectric prosthesis, etc. Diabetics dependent on insulin or oral hypoglycemic medications Known cardiovascular disease such as arrhythmias, congestive heart failure Cardiac surgeries such as cardiac bypass, heart transplant surgery, pacemakers. Prior surgical interventions for body sculpting of thighs or buttocks such as liposuction Medical, physical or other contraindications for body sculpting/ weight loss Current use of medication known to affect weight levels and/or cause bloating or swelling and for which abstinence during the course of study participation is not safe or medically prudent Any medical condition known to affect weight levels and/or to cause bloating or swelling Active infection, wound or other external trauma to the area to be treated Pregnant, breast feeding, or planning pregnant before the end of the study Serious mental health illness Active or recurrent cancer or current chemotherapy and/or radiation treatment Negative affection to heat

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: Treatment Group<br>Treated group of subjects, serves as its own control | Device: BTL-703 (Treatment group)<br>* Treatment with BTL-703 device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist circumference reduction | The waist circumference measure will be conducted in accordance to the WHO STEPwise approach to surveillance (2008.) and NHLBI Obesity Education Initiative (2000.) recommendations. The waist circumference after the therapy will be compared to baseline. | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious adverse events following the treatment | Occurrence of serious adverse events will be followed throughout the whole study. | 5 months | 
| Photo evaluation | Correct identification of the pre- and post-treatment photos by blinded evaluators. | 5 months | 
| Subject Satisfaction | Subject Satisfaction Questionnaire will be given to subjects at every follow-up visit. | 5 months | 
| Therapy discomfort | Subject's discomfort (pain) level after each treatment will be assessed using the Discomfort Questionnaire. | 2 months |