Fat Burn
Conditions
Keywords
lipolysis, circumference reduction, non-invasive
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.
Interventions
DEVICEBTL-785F
Treatment with study device.
Sponsors
BTL Industries Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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; |
Countries
Bulgaria
Outcome results
None listed