BTL-785F Device for Non-invasive Lipolysis and Circumference Reduction of the Abdomen
- Conditions
- Fat Burn
- Interventions
- Device: BTL-785F
- Registration Number
- NCT04621019
- Lead Sponsor
- BTL Industries Ltd.
- Brief Summary
This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with BTL-785-1 applicator for non-invasive lipolysis (breakdown of fat) of the abdomen and reduction in circumference of the abdomen.
Safety measures will include documentation of adverse events (AE) during and after the procedures.
Follow-ups visits at 1 month and 3 months after the final treatment will be held.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- Healthy male or female subjects over 21 years of age seeking treatment for abdominal circumference reduction
- Subjects should be able understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form
- Presence of clearly visible fat deposits in the abdominal area as deemed appropriate by the Investigator (e.g. by pinch test or ultrasound fat thickness measurement)
- 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 abdominal 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.
- Willingness to comply with study instructions and to return to the clinic for required visits.
- Bacterial or viral infection, acute inflammations
- Impaired immune system
- Isotretinoin use in the past 12 months
- Skin related autoimmune diseases
- Radiation therapy and/or chemotherapy
- Poor healing and unhealed wounds in the treatment area
- Metal implants
- Permanent implant in the treated area
- Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body
- Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles
- History of any type of cancer
- Active collagen diseases
- Cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis and thrombosis)
- Pregnancy/nursing or IVF procedure
- History of bleeding coagulopathies, use of anticoagulants
- Any active condition in the treatment area, such as sores, psoriasis, eczema, etc.
- Any surgical procedure in the treatment area within the last three months or before complete healing
- Poorly controlled endocrine disorders, such as diabetes
- Acute neuralgia and neuropathy
- Kidney or liver failure
- Sensitivity disorders in the treatment area
- Varicose veins, pronounced edemas
- 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 abdominal area in the last six months
- Any other disease or condition (e.g. hernia) at the investigator discretion that may pose risk to the patient or compromise the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Non-invasive lipolysis and circumference reduction of the abdomen BTL-785F The treatment administration phase consists of four (4) treatment visits, delivered at least 1 week apart. Follow-ups visits at 1 month and 3 months after the final treatment will be held.
- Primary Outcome Measures
Name Time Method Statistically significant reduction of abdominal fat thickness determined with ultrasound 5 months To gather clinical evidence that BTL-785F system equipped with BTL-785-1 applicator is able to provide statistically significant reduction of at least 1,5 cm at the 3-months follow-up compared to baseline with a minimum response rate of 65% in both abdominal circumference and fat thickness.
- Secondary Outcome Measures
Name Time Method Evaluation of the safety of the BTL-785F device with BTL-785-1 applicator for non-invasive lipolysis and circumference reduction of the abdomen 5 months At every treatment visit after the first, prior to the procedure, the participants will be assessed for adverse effects resulting from the previous treatment(s) with the BTL-785F device.
Safety measures will include documentation of adverse events (AE) during and after the procedures.Assessment of the participants' satisfaction from the therapy measured via standard questionnaire 5 months Minimum 80% of treated subjects to report satisfaction (level satisfied and higher) with the therapy;
Trial Locations
- Locations (2)
Ambulatory for Individual Practice for Specialized Outpatient Medical Care in Dermatology and Venereology Dr. Ivelina Yordanova-Vasileva
🇧🇬Pleven, Bulgaria
Dr. Lekova Derm Ltd.
🇧🇬Sofia, Bulgaria