Improvement of Abdomen Appearance
Conditions
Brief summary
The subjects will be enrolled and assigned to a single study group. They will be required to complete two treatment visits and come for a biopsy procedure.
Interventions
DEVICEBTL-899
BTL-899 therapy
Sponsors
BTL Industries Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Age above 21 years and below 60 years * Voluntarily signing of the informed consent form * Women of child-bearing potential are required to use birth control measures during the whole duration of the study * Eligibility to fat tissue biopsy at surgeon discretion, incl. at least 3-4 cm pinchable fat in the abdominal area * Subjects willing and able to abstain from partaking in any 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
* Electronic implants (such as cardiac pacemakers, defibrillators and neurostimulators) * Cardiovascular diseases * 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 * Abdominal wall diastasis * Unstable weight within the last 6 months (change in weight ± 3%) * Previous body contouring treatments in the abdomen area in the last three months * Any disease or condition contradicting the fat tissue biopsy at the surgeon discretion * Any disease or condition that may compromise the histologic observation at the pathologist discretion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Histology Examination | 4 months | Histological examination of the fat tissue after BTL-899 treatment at various days after the procedure |
| Evaluation of Satefy: Occurence of adverse events throughout the study | 4 months | Following the occurence of adverse events throughout the study. |
Countries
Bulgaria
Outcome results
None listed