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

NCT ID: NCT06017648

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-06
• Study Completion Date: 2024-02-29

Brief 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.

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.

Conditions

Body Sculpting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental: Group 1 - Non Invasive Ultrasound (FUBA5200)

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

Group Type: EXPERIMENTAL

Non Invasive Ultrasound (FUBA5200)

Intervention Type: DEVICE

the Focused Ultrasound Fat Reduction device (FUBA5200) is manufactured by Shanghai Carnation Medical Technology Co., Ltd

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

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

Group Type: ACTIVE_COMPARATOR

Non Invasive Ultrasound (Contour I V3)

Intervention Type: DEVICE

the Focused Ultrasound Fat Reduction device (Contour I V3) is manufactured by Syneron Medical Ltd.

Interventions

Non Invasive Ultrasound (FUBA5200)

the Focused Ultrasound Fat Reduction device (FUBA5200) is manufactured by Shanghai Carnation Medical Technology Co., Ltd

Intervention Type: DEVICE

Non Invasive Ultrasound (Contour I V3)

the Focused Ultrasound Fat Reduction device (Contour I V3) is manufactured by Syneron Medical Ltd.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Carnation Medical Technology Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Peking University Third Hospital

Beijing, , China

Site Status: RECRUITING

Huashan Hospital Fudan University

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

YuLan Chen

Role: CONTACT

chenyulan@cms.net.cn

0755-82418801

Facility Contacts

WenZhi Li

Role: primary

HongYu Xue

Role: primary

JinHua Xu

Role: primary

Other Identifiers

HJ002-07-001

Identifier Type: -

Identifier Source: org_study_id