A Multicenter Controlled Study to Evaluate Efficacy and Safety of Focused Ultrasound Device (FUBA… (NCT06017648) | Clinical Trial Compass
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A Multicenter Controlled Study to Evaluate Efficacy and Safety of Focused Ultrasound Device (FUBA5200) for Noninvasive Fat Reduction
China144 participantsStarted 2022-05-06
Plain-language summary
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.
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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);
What they're measuring
1
Reduction in circumference measurement of the abdomen from baseline
Timeframe: Week 10
Trial details
NCT IDNCT06017648
SponsorShanghai Carnation Medical Technology Co., Ltd
✕. 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;