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

Completed · Not applicable

Conditions studied: Dermatological Non-Disease

In brief

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.

Key facts

Study ID

NCT05896696

Run by

BeShape Technologies Ltd.

People needed

81

Starts

2022-04-28

Expected to finish

2023-04-27

Last updated by the study team

2024-10-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Chicago Cosmetic Surgery and Dermatology — Chicago, Illinois, United States
• Centro Poliklinika — Vilnius, Lithuania

Full record on ClinicalTrials.gov

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