A Multicenter Controlled Study to Evaluate Efficacy and Safety of Focused Ultrasound Device (FUBA5200) for Noninvasive Fat Reduction

Shanghai Carnation Medical Technology

Status: Enrolling

Conditions: Body Sculpting

Treatments: Device: Non Invasive Ultrasound (Contour I V3); Device: Non Invasive Ultrasound (FUBA5200)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06017648

HJ002-07-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age 18~55 years;
2. Abdominal fat thickness of at least 2.0 cm;
3. Body mass index (BMI) <28.0 kg/m2;
4. Simple localized obesity with abdominal subcutaneous fat accumulation;
5. 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%;
6. For women of childbearing potential with negative serum pregnancy tests at Screening/baseline;
7. Those who have not participated in any clinical trials within three months prior to enrollment.

Exclusion criteria

1. Pregnant women, breastfeeding women or women at childbearing age who are expected to become pregnant or who are prone to contraceptive failure;
2. Subjects with pacemakers, implantable cardiac defibrillators or other electromagnetic implantable medical systems;
3. History of underlying medical conditions such as hypertension (blood pressure ≥ 140/90 mmHg), hyperlipidemia, diabetes, hyperthyroidism or hypothyroidism;
4. 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);
5. Patients with autoimmune or connective tissue diseases or malignant tumors;
6. 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);
7. Abnormal coagulation, abnormal blood counts, and dyslipidemia (total cholesterol, triglycerides, or LDL exceeding 20% of the upper limit of the normal range);
8. 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;
9. 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;
10. Abdominal hernia, diastasis recti or known abdominal aortic aneurysm (abdominal treatment);
11. History of fat reduction procedures at the treatment site (e.g., undergoing liposuction, surgery, use of lipolytic agents, etc.) or history of other surgeries or presence of implants at the required treatment site and its adjacent areas;
12. Non-invasive or minimally invasive fat reduction, skin tightening, or lipolysis treatments such as ultrasound, radiofrequency, etc., on the abdomen within the past 6 months;
13. Received weight loss treatment methods (including medication, physical therapy and controlled diet and exercise therapy) within the past 1 month;
14. Those who are allergic to medical device treatments and excipients and acoustic gel for this treatments;
15. Concomitant use with anti-aggregating drugs (non-steroidal anti-inflammatory drugs NSAIDS, etc.). o) Concomitant use with anticoagulant drugs (Warfarin, etc.);
16. Subjects with unrealistic expectations of therapeutic efficacy;
17. Patients with legally defined disabilities (blindness, deafness, dumbness, mental retardation, physical disability);
18. Persons with mental disorders;
19. Patients who are unable or unwilling to comply with the requirements of the study;
20. Subject is in other conditions deemed unsuitable for the trial by the investigator judgment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

144 participants in 2 patient groups

Experimental: Group 1 - Non Invasive Ultrasound (FUBA5200)

Experimental group

Description:

Treatment with the Focused Ultrasound Fat Reduction device (FUBA5200) 4 times in total, once every two weeks

Treatment:

Device: Non Invasive Ultrasound (FUBA5200)

Active comparator: Group 2 - Non Invasive Ultrasound (Contour I V3)

Active Comparator group

Description:

Treatment with the focused ultrasound fat reduction device (Contour I V3) 4 times in total, once every two weeks

Treatment:

Device: Non Invasive Ultrasound (Contour I V3)