Clinical trial NCT04643275: Effect of BTL-899 Device for Non-invasive Lipolysis on Human Upper Arms
Official title: Effect of BTL-899 Device for Non-invasive Lipolysis on Human Upper Arms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fat Burn
Lead sponsor: BTL Industries Ltd.
Sponsor class: INDUSTRY
First posted: 2020-11-25
Enrollment: 45
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the clinical safety and the performance of the BTL-899 device during the treatment of upper arms.

Detailed description: The aim of the study is to confirm the efficacy and the safety of the treatment. The efficacy (reduction of excess adipose tissue) will be assessed via correct identification of pre-treatment and 3-months follow-up images by at least two out of three independent blinded evaluators. The fat reduction will be also measured by means of ultrasound. Comfort and satisfaction will be assessed via standard questionnaires.

Safety measures will include documentation of adverse events (AE) during and after the procedures.

Eligibility criteria: 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 the patient or compromise the study

Primary outcomes:
measure: Statistically significant reduction of fat thickness in the upper arms evaluated by photographs
timeFrame: 5 months
Secondary outcomes:
measure: Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire
timeFrame: 7 months
measure: Evaluation of the participants' satisfaction with the therapy evaluated via standard questionnaires
timeFrame: 5 months
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Dr Denkova Dermatology
Study officials:
References: