Prospective, Multicenter, Randomized, Blinded, Parallel-Controlled Trial on the Efficacy and Safety of the Focused Ultrasound Device (FUBA5200) for Noninvasive Fat Reduction

Shanghai Carnation Medical Technology Co., Ltd3 sites in 1 country144 target enrollmentMay 6, 2022

ConditionsBody Sculpting

Overview

Phase: N/A
Intervention: Not specified
Conditions: Body Sculpting
Sponsor: Shanghai Carnation Medical Technology Co., Ltd
Enrollment: 144
Locations: 3
Primary Endpoint: Reduction in circumference measurement of the abdomen from baseline
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

May 6, 2022

End Date

February 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai Carnation Medical Technology Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18\~55 years;
•Abdominal fat thickness of at least 2.0 cm;
•Body mass index (BMI) \<28.0 kg/m2;
•Simple localized obesity with abdominal subcutaneous fat accumulation;
•Those who voluntarily participate in this clinical trial and sign informed consent, agreeing to maintain the same dietary and exercise habits during the study period as before treatment, and to maintain changes in body weight of no more than ±6%;
•For women of childbearing potential with negative serum pregnancy tests at Screening/baseline;
•Those who have not participated in any clinical trials within three months prior to enrollment.

Exclusion Criteria

•Pregnant women, breastfeeding women or women at childbearing age who are expected to become pregnant or who are prone to contraceptive failure;
•Subjects with pacemakers, implantable cardiac defibrillators or other electromagnetic implantable medical systems;
•History of underlying medical conditions such as hypertension (blood pressure ≥ 140/90 mmHg), hyperlipidemia, diabetes, hyperthyroidism or hypothyroidism;
•Patients who are positive for 4 preoperative infection tests (including anti-human immunodeficiency virus antibodies, syphilis spirochete-specific antibodies, hepatitis C virus antibodies, and hepatitis B surface antigen, in which any one of these is positive);
•Patients with autoimmune or connective tissue diseases or malignant tumors;
•Those with cardiac, hepatic or renal insufficiency (Alanine aminotransferase or Aspartate Transaminase \> 1.5 times the upper limit of normal; Blood urea nitrogen \> 1.5 times the upper limit of normal or Cr \> the upper limit of normal; ischemic heart disease; cardiac valvular disease; congestive heart failure);
•Abnormal coagulation, abnormal blood counts, and dyslipidemia (total cholesterol, triglycerides, or LDL exceeding 20% of the upper limit of the normal range);
•History of exposure to high fat-soluble compounds (e.g., pesticides, herbicides, or drugs known to be stored in fat, except oral contraceptives), use of retinoids within the last 1 month;
•History of lacerations or dermatologic conditions, active dermatologic conditions, known tendency to form keloids or poor wound healing in the area of treatment; current infectious lesions in the area of treatment and its immediate vicinity;
•Abdominal hernia, diastasis recti or known abdominal aortic aneurysm (abdominal treatment);

Outcomes

Primary Outcomes

Reduction in circumference measurement of the abdomen from baseline

Time Frame: Week 10

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).

Secondary Outcomes

Reduction in circumference measurement of the abdomen every visit(Day 0、1 and week 2、4、6)
Assess abdominal subcutaneous fat thickness reduction from baseline to the last visit(Week 10)
Assess subject satisfaction measured with a self-assessment questionnaire (Likert scale)(Week 10)