At a glance
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Prospective Clinical Study for the Evaluation of the Efficacy and Safety of the BeShape One Device for Non-invasive Waist Circumference Reduction
In Brief
A clinical study evaluating BeShape One for Dermatological Non-Disease. Completed, enrolled 81 participants across 2 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Single treatment with the BeShape One device. Participants will receive treatment on at least 4 abdomen/flanks treatment areas and up to 6 treatment areas, at the discretion of the investigator. The subject will receive one treatment on each treatment area.