Effect of the BTL-899 Therapy for Non-invasive Lipolysis and Circumference Reduction of Abdomen When Compared to a Sham Treatment
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About
The study is a prospective single-blinded two-arms study that includes three treatment procedures and four follow-up visits
Full 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 single-blinded two-arms study. The subjects will be enrolled and assigned into a two study groups. All 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.
Enrollment
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Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
60 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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