Effect of BTL-899 Device for Non-invasive Lipolysis on Human Upper Arms
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fat Burn
- Sponsor
- BTL Industries Ltd.
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Statistically significant reduction of fat thickness in the upper arms evaluated by photographs
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This study will evaluate the clinical safety and the performance of the BTL-899 device during the treatment of upper arms.
Detailed Description
The aim of the study is to confirm the efficacy and the safety of the treatment. The efficacy (reduction of excess adipose tissue) will be assessed via correct identification of pre-treatment and 3-months follow-up images by at least two out of three independent blinded evaluators. The fat reduction will be also measured by means of ultrasound. Comfort and satisfaction will be assessed via standard questionnaires. Safety measures will include documentation of adverse events (AE) during and after the procedures.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Body Mass Index (BMI) of 20 to 35 kg/m
- •Visible excess of adipose tissue at the treatment site
- •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 in the area 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 the study participation.
Exclusion Criteria
- •Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
- •Cardiovascular diseases
- •Vascular diseases (such as chronic venous insufficiency, deep venous thrombosis, varicose veins, etc.)
- •Disturbance of temperature or pain perception
- •Pulmonary insufficiency
- •Metal implants
- •Drug pumps
- •Malignant tumor
- •Hemorrhagic conditions
- •Septic conditions and empyema
Outcomes
Primary Outcomes
Statistically significant reduction of fat thickness in the upper arms evaluated by photographs
Time Frame: 5 months
To gather clinical evidence that the BTL-899 device is able to induce non-invasive lipolysis when used on upper arms. The primary efficacy outcome measure is a minimum 75% of the subjects' pre-treatment and 3-months follow-up images to be correctly identified by at least two of three independent blinded evaluators.
Secondary Outcomes
- Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire(7 months)
- Evaluation of the participants' satisfaction with the therapy evaluated via standard questionnaires(5 months)