Body SculptingNCT06017648
A Multicenter Controlled Study to Evaluate Efficacy and Safety of Focused Ultrasound Device (FUBA5200) for Noninvasive Fat Reduction
A study testing Non Invasive Ultrasound (FUBA5200) and Non Invasive Ultrasound (Contour I V3) in people with Body Sculpting, run by Shanghai Carnation Medical Technology Co., Ltd at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Sculpting
- What is being tested?
- Non Invasive Ultrasound (FUBA5200) and Non Invasive Ultrasound (Contour I V3)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 3 sitesChina
- Study dates
- 6 May 2022to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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);
- 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;
- 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;
- Received weight loss treatment methods (including medication, physical therapy and controlled diet and exercise therapy) within the past 1 month;
- Those who are allergic to medical device treatments and excipients and acoustic gel for this treatments;
- Concomitant use with anti-aggregating drugs (non-steroidal anti-inflammatory drugs NSAIDS, etc.). o) Concomitant use with anticoagulant drugs (Warfarin, etc.);
- Subjects with unrealistic expectations of therapeutic efficacy;
- Patients with legally defined disabilities (blindness, deafness, dumbness, mental retardation, physical disability);
- Persons with mental disorders;
- Patients who are unable or unwilling to comply with the requirements of the study;
- Subject is in other conditions deemed unsuitable for the trial by the investigator judgment.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality
WenZhi Li
- Recruiting
Peking University Third Hospital
Beijing
HongYu Xue
- Recruiting
Huashan Hospital Fudan University
Shanghai
JinHua Xu
About this study
Official title: Prospective, Multicenter, Randomized, Blinded, Parallel-Controlled Trial on the Efficacy and Safety of the Focused Ultrasound Device (FUBA5200) for Noninvasive 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.
Read the 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
- Being tested
- Non Invasive Ultrasound (FUBA5200), Non Invasive Ultrasound (Contour I V3)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non Invasive Ultrasound (FUBA5200)Device
the Focused Ultrasound Fat Reduction device (FUBA5200) is manufactured by Shanghai Carnation Medical Technology Co., Ltd
Non Invasive Ultrasound (Contour I V3)Device
the Focused Ultrasound Fat Reduction device (Contour I V3) is manufactured by Syneron Medical Ltd.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Non Invasive Ultrasound (FUBA5200) |
| 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 Receives: Device: Non Invasive Ultrasound (Contour I V3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Week 10
Secondary outcomes (3)
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).
Measured: Day 0、1 and week 2、4、6
Assess abdominal subcutaneous fat thickness reduction from baseline to the last visit
evaluate the effectiveness of the FUBA5200 System on abdominal subcutaneous fat thickness reduction of abdomen at visit 7.
Measured: 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.
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start6 May 2022
- Primary completionNov 2023 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body SculptingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Carnation Medical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017648
- Sponsor's protocol ID
- HJ002-07-001
- Status last verified
- Aug 2023
- First submitted
- 21 Aug 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Randomized, Blinded, Parallel-Controlled Trial on the Efficacy and Safety of the Focused Ultrasound Device (FUBA5200) for Noninvasive Fat Reduction
- ClinicalTrials.gov ID
- NCT06017648
- Acronym / sponsor ID
- HJ002-07-001
- Conditions
- Body Sculpting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Shanghai Carnation Medical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 6 May 2022 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Group 1 - Non Invasive Ultrasound (FUBA5200) | Experimental | Device: Non Invasive Ultrasound (FUBA5200)Treatment with the Focused Ultrasound Fat Reduction device (FUBA5200) 4 times in total, once every two weeks |
| Active comparator: Group 2 - Non Invasive Ultrasound (Contour I V3) | Active comparator | Device: 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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%;
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non Invasive Ultrasound (FUBA5200)the Focused Ultrasound Fat Reduction device (FUBA5200) is manufactured by Shanghai Carnation Medical Technology Co., Ltd | Device | Experimental: Group 1 - Non Invasive Ultrasound (FUBA5200) |
| Non Invasive Ultrasound (Contour I V3)the Focused Ultrasound Fat Reduction device (Contour I V3) is manufactured by Syneron Medical Ltd. | Device | Active comparator: Group 2 - Non Invasive Ultrasound (Contour I V3) |
Primary outcome
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).
3 secondary outcomes
Reduction in circumference measurement of the abdomen every visit
Time frame: Day 0、1 and week 2、4、6
Assess abdominal subcutaneous fat thickness reduction from baseline to the last visit
Time frame: Week 10
Assess subject satisfaction measured with a self-assessment questionnaire (Likert scale)
Time frame: Week 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non Invasive Ultrasound (FUBA5200) and Non Invasive Ultrasound (Contour I V3) in people with Body Sculpting, run by Shanghai Carnation Medical Technology Co., Ltd at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YuLan Chen (0755-82418801, chenyulan@cms.net.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in circumference measurement of the abdomen from baseline (time frame: Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.