5 Clinical Trials for Various Conditions
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 evaluates the effectiveness and safety of externally applied lower frequency ultrasound to the waist/abdominal region of adults to achieve a reduction of fat cells/tissues below the skin, evidenced by a reduction in patient waist circumference.
The YOLO TOUCH consists of a console and multi-probes that are placed on the treatment area that emit laser light to reduce the circumference waistline.
The study is a prospective multi-center open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and four follow-up visits, 1 month, 3, 6 and 12 months after the final treatment. At the baseline visit photographs of the abdomen will be taken. In addition, patient umbilical circumference will be measured and the subject's weight will be recorded. In addition, at the last therapy visit, subjects will receive Subject Satisfaction and Therapy Comfort Questionnaires to fill in. Safety measures will include documentation of adverse events (AE) including subject's experience of pain or discomfort after the procedure. Following each treatment administration and at the follow-up visits, subjects will be checked for immediate post-procedure adverse event assessment. Post-procedure evaluation (follow-up visits) will be conducted 1 month, 3, 6 and 12 months after the final treatment. Umbilical circumference and weight measure will be conducted at every follow-up visit. Also, subject's satisfaction will be noted. During the first (1 month), third (6 months) and last (12 months) follow-up visits, photographs of abdomen will be taken.
The purpose of this study is to test the ability of the lay end user to understand the information contained in the User's Guide; to correctly identify patients who are suitably qualified to receive treatment; and to correctly administer the treatment with the Erchonia ZERONA® Z6 for circumference reduction of the waist, hips and thighs in an over-the-counter setting.