Fat Burn Clinical Trial
Official title:
Evaluation of the Safety and the Efficacy of the of BTL-785F Device for Non-invasive Lipolysis and Circumference Reduction of the Abdomen
Verified date | April 2023 |
Source | BTL Industries Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | January 26, 2023 |
Est. primary completion date | November 8, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Bulgaria | Ambulatory for Individual Practice for Specialized Outpatient Medical Care in Dermatology and Venereology Dr. Ivelina Yordanova-Vasileva | Pleven | |
Bulgaria | Dr. Lekova Derm Ltd. | Sofia |
Lead Sponsor | Collaborator |
---|---|
BTL Industries Ltd. |
Bulgaria,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Statistically significant reduction of abdominal fat thickness determined with ultrasound | 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. | 5 months | |
Secondary | Evaluation of the safety of the BTL-785F device with BTL-785-1 applicator for non-invasive lipolysis and circumference reduction of the abdomen | 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. |
5 months | |
Secondary | Assessment of the participants' satisfaction from the therapy measured via standard questionnaire | Minimum 80% of treated subjects to report satisfaction (level satisfied and higher) with the therapy; | 5 months |
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