Effect of the BTL-899 Therapy for Non-invasive Lipolysis and Circumference Reduction of Abdomen (NCT03270150) | Clinical Trial Compass
CompletedNot Applicable
Effect of the BTL-899 Therapy for Non-invasive Lipolysis and Circumference Reduction of Abdomen
Bulgaria40 participantsStarted 2017-09-01
Plain-language summary
The study is a prospective open-label single-arm study that includes three treatment procedures and four follow-up visits.
Who can participate
Age range22 Years
SexALL
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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
What they're measuring
1
Efficacy of the BTL-899 treatment for abdomen circumference reduction after the final follow-up visit