Adipose Tissue Reduction
Conditions
Brief summary
The study is a prospective two-arm, open-label, interventional study with four treatment procedures and two follow-up visits.
Detailed description
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.
Interventions
DEVICEBTL-899
Treatment with study device.
Sponsors
BTL Industries Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Fat Thickness Measured via Ultrasound | 6 months | 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. |
| Participants' Satisfaction Measured Via Questionnaires | 6 months | 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. |
| Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire | 6 months | 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. |
Countries
Bulgaria
Outcome results
None listed