Status:
COMPLETED
Effect of the BTL-899 Therapy for Non-invasive Lipolysis and Circumference Reduction of Abdomen
Lead Sponsor:
BTL Industries Ltd.
Conditions:
Improvement of Abdomen Appearance
Eligibility:
All Genders
22+ years
Phase:
NA
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 stud...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03270150
Start Date
September 1 2017
End Date
October 3 2018
Last Update
April 12 2023
Active Locations (1)
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1
Aesthe Clinic
Sofia, Bulgaria, 1700