Clinical trial NCT04221646: Non-invasive Lipolysis on Human Thighs and Saddlebags
Official title: Effect on BTL-899 Device for Non-invasive Lipolysis on Human Thighs and Saddlebags
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adipose Tissue Reduction
Lead sponsor: BTL Industries Ltd.
Sponsor class: INDUSTRY
First posted: 2020-01-09
Enrollment: 47
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a prospective two-arm, open-label, interventional study with four treatment procedures and two follow-up visits.

Detailed description: This study aims to evaluate the clinical safety and efficacy of the BTL-899 device for non-invasive lipolysis and fat reduction in the thigh and saddlebag area. This is a prospective, open-label, two-arm study; therefore the participants will be assigned to two study groups. Each participant will complete 4 treatment visits and 2 follow-up visits.

Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) of 20 to 35 kg/m2.
* Visible excess of adipose tissue at the treatment sites (ARM 1 - thigh area; ARM 2 - saddlebags 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.
* No procedure for fat reduction (including cellulite treatment) 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 21 and 70 years.

Exclusion Criteria:

* Electronic implants (such as intrauterine device, cardiac pacemakers, defibrillators, and neurostimulators)
* Cardiovascular diseases
* Vascular diseases (such as chronic venous insufficiency, deep venous thrombosis, varicose veins, etc.)
* Femoral or inguinal hernia
* 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
* Scars, open lesions, and wounds at the treatment area
* Basedow's disease
* 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 thighs area in the last six months
* Any other disease or condition at the investigator's discretion

Primary outcomes:
measure: Changes in Fat Thickness Measured via Ultrasound
timeFrame: 6 months
measure: Participants' Satisfaction Measured Via Questionnaires
timeFrame: 6 months
measure: Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Aesthe Clinic
Study officials:
References: