Status:
COMPLETED
Effect of BTL-899 Device for Non-invasive Lipolysis on Human Flanks
Lead Sponsor:
BTL Industries Ltd.
Conditions:
Fat Burn
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This study will evaluate the clinical safety and the performance of the BTL-899 device (with its 899-AP-C-4 and 899-AP-C-5 applicators) during treatment of the flanks (also known as "love handles"). T...
Eligibility Criteria
Inclusion
- Body Mass Index (BMI) of 20 to 35 kg/m2.
- Visible excess of adipose tissue confirmed with pinch test at the flanks ("love handles") area.
- 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.
- Successful initial determination of the flanks' fat thickness by means of ultrasound.
- No procedure for fat reduction at the treated 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 study participation.
- Age between 18 and 70 years.
Exclusion
- Electronic implants (such as intrauterine device, cardiac pacemakers, defibrillators, and neurostimulators)
- Metal implants
- Drug pumps
- Malignant tumor
- Pulmonary insufficiency
- Injured or otherwise impaired muscles in the treatment area
- Cardiovascular diseases
- Disturbance of temperature or pain perception
- Hemorrhagic conditions
- Septic conditions and empyema
- Acute inflammations
- Systemic or local infection such as osteomyelitis and tuberculosis
- Contagious skin disease
- Elevated body temperature
- Pregnancy, postpartum period, nursing
- Graves' disease
- Scars, open lesions, and wounds at the treatment area
- Abdominal hernia
- Gynecological disease incl. inflammation in the pelvis
- Hip and rib cage trauma or recent surgery of those
- Previous liposuction in the treatment area in the last six months
- Unstable weight within the last 6 months (change in weight ± 3%)
- Previous body contouring or cellulite treatments in the flanks area in the last six months
- Any other disease or condition at the investigator's discretion
Key Trial Info
Start Date :
March 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2023
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT05260164
Start Date
March 11 2022
End Date
January 30 2023
Last Update
April 12 2023
Active Locations (1)
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1
Outpatient Practice for Specialized Medical Care - Individual practice for specialized medical dermatology care Mariya Genova MD
Plovdiv, Bulgaria