Effect of BTL-899 Device for Non-invasive Lipolysis on Human Upper Arms (NCT04643275) | Clinical Trial Compass
CompletedNot Applicable
Effect of BTL-899 Device for Non-invasive Lipolysis on Human Upper Arms
Bulgaria45 participantsStarted 2020-10-15
Plain-language summary
This study will evaluate the clinical safety and the performance of the BTL-899 device during the treatment of upper arms.
Who can participate
Age range21 Years – 70 Years
SexALL
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Inclusion Criteria:
* Body Mass Index (BMI) of 20 to 35 kg/m2.
* Visible excess of adipose tissue at the treatment site
* 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 in the area 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 the study participation.
Exclusion Criteria:
* Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
* Cardiovascular diseases
* Vascular diseases (such as chronic venous insufficiency, deep venous thrombosis, varicose veins, etc.)
* 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 in the arms
* Scars, open lesions, and wounds at the treatment area
* Basedow's disease
* Previous liposuction in the treatment area in the last six months
* Any other disease or condition at the investigator's discretion, e.g. dislocated shoulder or carpal tunnel syndrome than can pose danger to th…
What they're measuring
1
Statistically significant reduction of fat thickness in the upper arms evaluated by photographs