Efficacy and Safety of the BeShape One Device for Non-invasive Waist Circumference Reduction (NCT05896696) | Clinical Trial Compass
CompletedNot Applicable
Efficacy and Safety of the BeShape One Device for Non-invasive Waist Circumference Reduction
United States, Lithuania81 participantsStarted 2022-04-28
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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.
. 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.