The goal of this clinical trial is to evaluate the safety and efficacy of the BeShape One device for non-invasive waist circumference reduction in adults between the ages of 18 and 65. The main question\[s\] it aims to answer are: * reduction in waist circumference following treatment with the BeShape One device at the final 6 and 12-week follow-up visits compared to baseline * Subject improvement and satisfaction * Investigator satisfaction * Subject comfort/pain level Participants will undergo a single treatment with the BeShape One device at the Baseline visit and will return for two follow up visits at 6 and 12 weeks post treatment. Researchers will compare the results at the follow up visits to Baseline.
This study is a prospective, baseline controlled, multi-center, one arm clinical study aimed to assess the efficacy and safety of the BeShape OneTM device for waist circumference reduction. Seventy (70) subjects in two investigational sites will be enrolled in this study. All subjects will undergo an assessment of their general health. A single treatment utilizing the BeShape OneTM device will be administered. During the follow-up period, visits will be conducted as follows: 6 weeks (6wk FU), and 12 weeks (12wk FU) post treatment. Subject's waist circumference will be measured at baseline (before treatment) and at each of the follow up visits. Circumference reduction will be assessed at each post baseline visit, using a standardized and validated measuring technique. Additionally, investigator and subject assessments will be completed at each follow up visit. Photography of the treatment areas will be performed under visible light conditions of the front, right, left and back view of the subjects at the baseline visit (before first treatment) and at the last follow-up visit (12wk FU).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
81
Single treatment with the BeShape One device. Participants will receive treatment on at least 4 abdomen/flanks treatment areas and up to 6 treatment areas, at the discretion of the investigator. The subject will receive one treatment on each treatment area.
Chicago Cosmetic Surgery and Dermatology
Chicago, Illinois, United States
Centro Poliklinika
Vilnius, Lithuania
Change in Waist Circumference
Waist circumference change (in cm) following BeShape treatment at the final 12 week follow-up visit compared to baseline.
Time frame: Baseline and 12 weeks
Change in Waist Circumference
Waist circumference change (in cm) following BeShape treatment at the 6 week follow up visits compared to baseline.
Time frame: Baseline and 6 weeks
Subject Improvement
Subject improvement is measured using the Global Aesthetic Improvement (GAI) scale at each follow up visit. The GAI scale is a 7 point scale ranging from significantly worse (-3) to significant improvement (+3). A higher GAI score indicates a greater improvement.
Time frame: 6 and 12 weeks
Subject Satisfaction
Subject satisfaction is measured using a 5 point Likert scale at each follow up visit. The 5 point Likert scale ranges from very dissatisfied (-2) to very satisfied (+2). A higher score indicates greater subject satisfaction.
Time frame: 6 and 12 weeks
Investigator Satisfaction
Investigator satisfaction is measuring using the Clinical Global Aesthetic Improvement (CGAI) scale at each follow up visit. The CGAI scale is a 7 point scale ranging from significantly worse (-3) to significant improvement (+3). A higher CGAI score indicates a greater improvement.
Time frame: 6 and 12 weeks
Subject Comfort/Pain
Subject comfort/pain level will be assessed immediately after treatment using the Numeric Pain Rating Scale (NPRS). The NPRS scale is a 10 point scale ranging from 0 (no pain) to 10 (worst possible pain). A higher NPRS score indicates a greater pain level.
Time frame: Immediately after the treatment procedure at Baseline, up to 5 minutes
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