Evaluation of Safety and Efficacy of the BTL-899 Device for Non-invasive Lipolysis and Circumference Reduction of Abdomen
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Improvement of Abdomen Appearance
- Sponsor
- BTL Industries Ltd.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Efficacy of the BTL-899 treatment for abdomen circumference reduction after the final follow-up visit
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The study is a prospective open-label single-arm 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 open-label single-arm study. The subjects will be enrolled and assigned into a single study group. 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.
Investigators
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
Outcomes
Primary Outcomes
Efficacy of the BTL-899 treatment for abdomen circumference reduction after the final follow-up visit
Time Frame: 4 months
Evaluation of change in abdomen circumference using tape measurements in cm at the final follow-up visit.
Occurrence of adverse events
Time Frame: 7 months
The occurrence of adverse events will be followed throughout the whole study.
Secondary Outcomes
- Efficacy of the BTL-899 treatment for abdomen circumference reduction(4 months)
- Therapy comfort during the study treatment.(1 month)
- Efficacy of BTL-899 treatment for fat and circumference reduction in abdomen, as assessed by two blinded evaluators(4 months)
- Subject's satisfaction with study treatment(4 months)
- Ultrasound imaging(4 months)