Reduction in Abdominal Circumference Clinical Trial
Official title:
A Baseline Controlled Study to Evaluate the Effectiveness of the UltraShape® Contour I - Y System for Non-Invasive Reduction in Abdominal Circumference
The UltraShape® Contour I- Y system uses focused ultrasound to produce localized mechanical
motion within fat tissues and cells for the purpose of producing mechanical cellular
membrane disruption. It is intended for reduction in body circumference.
The primary objective of this study is to evaluate the efficacy of the Contour I - Y System
on abdominal circumference reduction relative to baseline pretreatment values using
different treatment methods.
The primary efficacy endpoint in this trial is Statistical Difference of Circumference
reduction between Baseline measurement and at follow-up measurement.
n/a
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment