Clinical trial NCT04000945: Effect of the BTL-899 Therapy for Non-invasive Lipolysis and Circumference Reduction of Abdomen When Compared to a Sham Treatment
Official title: Evaluation of Safety and Efficacy of the BTL-899 Device for Non-invasive Lipolysis and Circumference Reduction of Abdomen When Compared to a Sham Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Improvement of Abdomen Appearance
Lead sponsor: BTL Industries Ltd.
Sponsor class: INDUSTRY
First posted: 2019-06-27
Enrollment: 60
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a prospective single-blinded two-arms study that includes three treatment procedures and four follow-up visits

Detailed description: This study will evaluate the clinical efficacy and safety of the BTL-899 device for non-invasive lipolysis and circumference reduction of abdomen. The study is a prospective single-blinded two-arms study. The subjects will be enrolled and assigned into a two study groups. All subjects will complete three (3) treatment visits and will be invited to four (4) follow-up visits 1, 2, 3 and 6-months after the final treatment. 6-months follow-up visit is the optional one.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of the BTL-899 treatment for change in abdominal circumference
timeFrame: 4 months
measure: Occurrence of adverse events
timeFrame: 7 months
Secondary outcomes:
measure: Efficacy of BTL-899 treatment for abdominal fat and circumference reduction, as assessed by two blinded evaluators
timeFrame: 4 months
measure: Efficacy of the BTL-899 treatment for change in abdominal circumference
timeFrame: 4 months
measure: Efficacy of the BTL-899 treatment for abdominal fat reduction
timeFrame: 4 months
measure: Subject's satisfaction with study treatment
timeFrame: 4 months
measure: Therapy comfort during the study treatment.
timeFrame: 1 month
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Dr-Denkova Dermatology
Study officials:
References: