This clinical trial is a prospective, multicenter, randomized blinded, parallel controlled study. The purpose of this study is to evaluate the efficacy and safety of the Focused UltrasoundDevice (FUBA5200) for Fat Reduction.
This clinical trial is a prospective, multicenter, randomized blinded, parallel controlled study. The purpose of this study is to evaluate the efficacy and safety of the Focused UltrasoundDevice (FUBA5200) for Fat Reduction.The primary objective of this study is to evaluate the effectiveness of the FUBA5200 System on abdominal circumference reduction at last visit relative to active comparator.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
144
the Focused Ultrasound Fat Reduction device (FUBA5200) is manufactured by Shanghai Carnation Medical Technology Co., Ltd
the Focused Ultrasound Fat Reduction device (Contour I V3) is manufactured by Syneron Medical Ltd.
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGPeking University Third Hospital
Beijing, China
RECRUITINGHuashan Hospital Fudan University
Shanghai, China
RECRUITINGReduction in circumference measurement of the abdomen from baseline
The primary objective of this study is to evaluate the effectiveness of the FUBA5200 System on abdominal circumference reduction at last visit relative to active comparator (last visit (visit 7):28 days after the 4th treatment).
Time frame: Week 10
Reduction in circumference measurement of the abdomen every visit
The second objective of this study is to evaluate the effectiveness of the FUBA5200 System on abdominal circumference reduction of abdomen every visit (visit 2, 3, 4, 5 and 6).
Time frame: Day 0、1 and week 2、4、6
Assess abdominal subcutaneous fat thickness reduction from baseline to the last visit
evaluate the effectiveness of the FUBA5200 System on abdominal subcutaneous fat thickness reduction of abdomen at visit 7.
Time frame: Week 10
Assess subject satisfaction measured with a self-assessment questionnaire (Likert scale)
Subject satisfaction with FUBA5200 as determined by the results of a subjects satisfaction questionnaire at the visit 7. Subject satisfaction was designed as a 5-level standard (0-5),the higher the level, the higher the satisfaction.
Time frame: Week 10
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