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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Group 1 - Non Invasive Ultrasound (FUBA5200) | Experimental | Treatment with the Focused Ultrasound Fat Reduction device (FUBA5200) 4 times in total, once every two weeks |
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| Active comparator: Group 2 - Non Invasive Ultrasound (Contour I V3) | Active Comparator | Treatment with the focused ultrasound fat reduction device (Contour I V3) 4 times in total, once every two weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non Invasive Ultrasound (FUBA5200) | Device | the Focused Ultrasound Fat Reduction device (FUBA5200) is manufactured by Shanghai Carnation Medical Technology Co., Ltd |
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| Measure | Description | Time Frame |
|---|---|---|
| Reduction 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). | Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 0、1 and week 2、4、6 |
| Assess abdominal subcutaneous fat thickness reduction from baseline to the last visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| YuLan Chen | Contact | 0755-82418801 | chenyulan@cms.net.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | China |
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| Non Invasive Ultrasound (Contour I V3) | Device | the Focused Ultrasound Fat Reduction device (Contour I V3) is manufactured by Syneron Medical Ltd. |
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evaluate the effectiveness of the FUBA5200 System on abdominal subcutaneous fat thickness reduction of abdomen at visit 7. |
| 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. | Week 10 |
| Peking University Third Hospital | Recruiting | Beijing | China |
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| Huashan Hospital Fudan University | Recruiting | Shanghai | China |
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