6 Clinical Trials for Various Conditions
Open-label, baseline-controlled, multi-center study evaluating an electrical muscle stimulation system for circumferential reduction and muscle toning. The study will enroll up to 100 subjects desiring circumferential reduction and muscle toning. Each subject will receive up to 12 bi-weekly treatments over a 6-week period. Follow Up Visits planned for 2, 30- and 90-days post treatment. Measurement outcomes will be compared to baseline.
The rationale for the selection of Outcome Measures is the compliance with FDA regulations as pertain to medical devices with a moderate level of risk of hazard leading to harm of the patient; firstly, the safety of the device in achieving the desired effect of its intended use when operated in the intended manner; and secondly, the effectiveness of the device in achieving its desired effect of its intended use in accordance with its proposed label and labeling. The rationale for the selection of the primary outcome measure is to satisfy the question of safety and effectiveness of the use of red-light exposure to reduce the circumference of overweight patients with a statistically significant Routine Use population size. Given that the Routine Use Data Analysis is open label and therefore not blinded, there is no need for a control group nor additional cohorts for varying levels of exposure and corresponding safety and/or effectiveness.
A long-term follow-up study to evaluate the safety and efficacy of the Cutera truSculpt radiofrequency device for circumferential reduction.
To evaluate the safety and efficacy of the Cutera truSculpt radiofrequency device for circumferential reduction.
The purpose of this study is to compare the clinical performance of the VelaShape III device with CoolSculpt for reduction of the waist, love handles and flanks.
Clinical study to evaluate the safety and efficacy of the NuEra Tight for circumferential reduction in the abdominal region within three treatment group