Efficacy and Safety of the BeShape One Device for Non-invasive Waist Circumference Reduction

Inclusion Criteria

• Female and male subjects ≥18 and ≤65 years of age.
• Abdominal fat thickness of at least 1.5 cm (measured by calibrated caliper).
• 18.5 ≤ BMI ≤ 33
• Women of childbearing potential (i.e., not post-menopausal or surgically sterilize) must have a negative urine pregnancy test. Participating women of childbearing potential must be using a medically acceptable form of birth control for at least 3 months prior to enrollment.
• Understand the study and volunteer to sign the informed consent.
• Willing to follow the treatment and follow up schedule and post-treatment care instructions.
• Willing to refrain from a change in diet, exercise or medication regimen for the duration of the study.
• Willing to have de-identified images of the treated areas taken for possible use in publications and presentations.

Exclusion Criteria

• Pregnant women, intending to become pregnant during the study, less than 12 months after delivery, breastfeeding, or less than 6 weeks after completing breastfeeding;
• Participation in another clinical study of another investigational device or drug involving the same anatomical site within the last 3 months, or, if it does not involve the same anatomical site, at the discretion of the researcher.
• Subjects with significant systemic disease, such as ongoing hyperlipidemia, diabetes mellitus, hepatitis or other liver disease, HIV-positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease, and malignant neoplasms; undergoing chronic steroid or immunosuppressive therapy.
• Subject having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions.
• An implanted pacemaker or any other implantable active device anywhere in the body.
• Subjects with thyroid disease and / or metabolic syndrome.
• Unstable weight within the last 6 months (i.e. + 3% weight change in the past six months).
• Local skin pathologies or natural structure loss in the treated area (hernia) and / or loss of sensation or dysesthesia in the treated area.
• Previous body contouring procedures in the treatment area within the past 12 months.
• History of abdominal surgery, including laparoscopic procedures.
• Caesarean section within 12 months.
• Any permanent or temporary implant in the treatment area such as metal plates or an injected chemical substance such as silicone.
• Actively expressed psychiatric or psychological state.
• Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count within the last 3 months.
• Any condition that, at the researcher's discretion, renders the subject unsuitable for participation in a clinical research study.