Improvement of Abdomen Appearance
Conditions
Brief summary
The study is a prospective open-label single-arm study that includes three treatment procedures and four follow-up visits.
Detailed description
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.
Interventions
DEVICEBTL-899
BTL-899
Sponsors
BTL Industries Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of the BTL-899 treatment for abdomen circumference reduction after the final follow-up visit | 4 months | Evaluation of change in abdomen circumference using tape measurements in cm at the final follow-up visit. |
| Occurrence of adverse events | 7 months | The occurrence of adverse events will be followed throughout the whole study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ultrasound imaging | 4 months | Evaluation of ultrasound images. |
| Efficacy of BTL-899 treatment for fat and circumference reduction in abdomen, as assessed by two blinded evaluators | 4 months | Evaluation of photographs before and after the treatment. |
| Therapy comfort during the study treatment. | 1 month | Therapy comfort during the treatment evaluated through the Therapy Comfort Questionnaire (10-point scale). |
| Subject's satisfaction with study treatment | 4 months | Subject's satisfaction with the therapy results evaluated through the Subject Satisfaction Questionnaire (5-point scale). |
| Efficacy of the BTL-899 treatment for abdomen circumference reduction | 4 months | Evaluation of change in abdomen circumference using tape measurements in cm at all study visits after the first therapy. |
Countries
Bulgaria
Outcome results
None listed