Radiofrequency and Targeted Pressure Energy for Cellulite Reduction

Study Overview
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Brief Summary
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This study will evaluate the clinical efficacy and safety of radiofrequency heating and targeted pressure energy for reduction in the appearance or cellulite. The study is a prospective multi-center open-label single-arm study. Subjects will be required to complete four (4) treatment visits and two to three follow-up visits - 1, 3 and 6 months after the last therapy visit. All of the study subjects will receive the treatment with the subject device.

Detailed Description
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This study will evaluate the clinical efficacy and safety of radiofrequency heating and targeted pressure energy for reduction in the appearance or cellulite. The study is a prospective multi-center open-label single-arm study. Subjects will be required to complete four (4) treatment visits and two to three follow-up visits - 1, 3 and 6 months after the last therapy visit. All of the study subjects will receive the treatment with the subject device. At the baseline visit subject's weight will be recorded, together with hip and thigh circumference. In addition, photographs of the treated area will be taken. The treatment administration phase will consist of four (4) treatments, delivered in 2-4 weeks. The applicator will be applied over the treatment area. At the last therapy visit, the subject's weight will be recorded, together with hip and thigh circumference. Photographs of the treated area will be taken. In addition, subjects will receive Subject Satisfaction Questionnaire and Therapy Comfort Questionnaire to fill in. Safety measures will include documentation of adverse events (AE). Following each treatment administration and at all of the follow-up visits, subjects will be checked for immediate post-procedure adverse event assessment.

Official Title
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Radiofrequency and Targeted Pressure Energy for Cellulite Reduction

Conditions
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Cellulite, Cellulitis, Cellulitis of Leg

Intervention / Treatment
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* Device: BTL-084


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Voluntarily signed informed consent form Age ≥ 21 years Subject suffer from Grade 2 or Grade 3 cellulite as per Nürnberger-Muller Scale Subject did not experience weight change exceeding 2.5 kg (5 lb) in the preceding month BMI ≤ 33 kg/m2 Women of childbearing 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 skin tightening and cellulite reduction during study participation Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without affecting significant change in either direction during study participation Exclusion Criteria: Bacterial or viral infection, acute inflammations Impaired immune system Autoimmune disease Diabetes Herpes Simplex Isotretinoin in the past 12 months Scleroderma Radiation therapy Burns in the treatment area Poor healing in the treatment area Metal implants Implantable pacemaker or automatic defibrillator / cardioverter Ablative / non-ablative cosmetic intervention (deep peeling) in the past 3 months Cancer and tumor diseases Active collagen diseases Cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis and thrombosis) Pregnancy / nursing or IVF procedure Acute neuralgia and neuropathy Blood disorders, risk of bleeding, bleeding tissues, peptic ulcers Eczema Rosacea Febrile conditions Kidney or liver failure Pronounced edemas, ascites, exudates Sensitivity disorders in the treatment area Varicose veins Local corticosteroid therapy

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BTL-084 Treatment<br>Radiofrequency and targeted pressure energy devices for the treatment of cellulite | Device: BTL-084<br>* Radiofrequency and targeted pressure energy devices for the treatment of cellulite<br>* Other names: Emtone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of cellulite severity change based on photographs before and after the study procedure according to the Cellulite Severity Scale | Three independent evaluators will evaluate photographs for a level of cellulite severity by assigning a score according to the Cellulite Severity Scale (CSS) validated by Hexsel et al. After follow-up visits are conducted, evaluators will be given a set of the coded photographs from each subject for an evaluation. The Cellulite Severity Scale evaluates five key morphological features of cellulite; number of depressions, depth of depressions, clinical appearance of evident raised lesions, presence of flaccidity and the grade of cellulite. Each item is graded from 0 to 3, allowing final classification of cellulite as mild, moderate and severe. | 6 months | 
| Photography evaluation according to the Global Aesthetic Improvement scale | Three independent evaluators will evaluate photographs for a level of appearance change by assigning a score according to the Global Aesthetic Improvement scale, where the lowest possible grade is (-1), worsened state and the highest is (3) very much improved. | 6 months | 
| Hip and Thigh Circumference Measure | Hip and thigh circumference measurements will be conducted at the baseline visit, after the last treatment and during all follow-up visits. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapy Comfort | The 10-point scale will be used for evaluating the comfort during the study treatment. Subjects will be evaluating the comfort/discomfort on a scale from 1 (No discomfort) to 10 (Unbearable discomfort) | 6 months | 
| Subject Satisfaction | The 5-point Likert scale Satisfaction questionnaire will be used to evaluate the participant's satisfaction with the therapy outcome. The subjects will be answering questions with possible answers varying from Strongly disagree to Strongly agree | 6 months |