BMINCT06850246
Safety and Effectiveness of High Frequency Electrocautery for Abdominal Fat Reduction
A study testing treatment of radiofrequency technology in people with BMI, run by Chinese Medical Association at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if the intervention of radiofrequency technology can help treat abdominal fat hypertrophy and skin laxity in adults. The main questions it aims to answer are Does radiofrequency technology lower the abdominal subcutaneous adipose tissue height by ultrasound measurement? Does… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- BMI
- What is being tested?
- treatment of radiofrequency technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 1 Apr 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntarily sign the informed consent form;
- Age 18 to 65 years old (including 18 and 65 years old), male or female;
- The body mass index (BMI) is in the range of 22 ~ 35 (kg/m2) (including the cut-off value);
- Maintain a stable weight and lifestyle (including calorie intake and exercise) throughout the clinical study period and within 6 months after the end of the study;
- Non-pregnant and breastfeeding women who have no pregnancy plan and voluntarily take effective contraceptive measures during the screening period and the whole trial period, and have no sperm or egg donation plan.
Who cannot join
- Patients who gained or lost more than 2.5 kg of weight during the study;
- Patients who have used weight loss drugs or participated in weight loss-related programs within 6 months of the start of the study;
- Have received or are about to receive surgery or liposuction in the abdomen, or have received lipolytic drugs injected in the abdomen, or have received abdominoplasty or cryo lipolysis;
- History of abdominal/waist-related trauma or scar;
- Patients with excessive accumulation of abdominal skin affecting the operation;
- Implantation of metal-related articles in the abdomen;
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- Patients suffering from severe systemic diseases that are life-threatening (such as cardiac insufficiency, renal insufficiency, etc.);
- Those who are equipped with dentures, pacemakers, or other internal metal implants (such as metal IUD rings, etc.);
- Local skin infection and open skin injury;
- Have a history of eating disorder or eating disorder;
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to learn if the intervention of radiofrequency technology can help treat abdominal fat hypertrophy and skin laxity in adults. The main questions it aims to answer are
- Does radiofrequency technology lower the abdominal subcutaneous adipose tissue height by ultrasound measurement?
- Does radiofrequency technology improve abdominal circumference data and lower the number of times participants need to use a rescue inhaler.
Read more
Researchers will compare the treatment side to the non-treatment side to see if radiofrequency technology works to treat abdominal fat hypertrophy and skin laxity?
Participants will:
- Accept the treatment of radiofrequency technology every week for 10 weeks.
- Visit the clinic 1 month and 3 months after the treatment ends for checkups and tests.
- Conditions
- BMI
- Being tested
- treatment of radiofrequency technology, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment of radiofrequency technologyDevice
When operating, first select 470 kHz frequency, CRT resistance probe for deep fat management operation for 10 minutes, and then select CET capacitance mode 470 kHz for superficial fat operation for 6 minutes. Then, select the 940 kHz frequency CET capacitance probe for epidermal tightening operation for 4 minutes. The temperature is set by the energy value. In CRT mode, the energy value is set to 70, and it can reach above 42 ℃ within one minute. In CET mode, the energy value setting is adjusted to 75. The operation mode is to gradually raise the temperature to the midline after partially increasing the temperature at the side of the waist. The technique is mainly to move in a circle and lift to the midline.
PlaceboDevice
Under the condition that the machine is not turned on, the treatment is performed in the same operation time, mode, and treatment area of the treatment group.
| Study group | Role | What they receive |
|---|---|---|
| radiofrequency technology | Experimental | First, the frequency of 470 kHz was selected, and the CRT resistance probe was performed for deep fat management operation for 10 minutes, and then the CET capacitive mode 470 kHz was selected for superficial fat operation for 6 minutes. Then, select the 940 kHz frequency CET capacitance probe for epidermal tightening operation for 4 minutes. The temperature is set by the energy value. In CRT mode, the energy value is set to 70, and it can reach above 42 ℃ within one minute. In CET mode, the energy value setting is adjusted to 75. The operation mode is to gradually raise the temperature to the midline after partially increasing the temperature at the side of the waist. The technique is mainly to move in a circle and lift to the midline. Receives: Device: treatment of radiofrequency technology |
| Placebo | Placebo comparator | Under the condition that the machine is not turned on, the treatment is performed in the same operation time, mode and treatment area of the treatment group. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height of abdominal subcutaneous adipose tissue
Ultrasound (GE LogiQ P6 ultrasound system, 132 GE Healthcare, Wauwatosa, WI) was used to measure the height of abdominal subcutaneous adipose tissue at four positions below the left and right abdomen three times respectively. A mold plate was designed to fix the ultrasound probe, centered on the umbilicus, and symmetrically symmetrically. Areas A and B are horizontal measurement of ultrasonic probe, which are located above and below the left/right abdomen respectively, and areas C and D are vertical measurement of ultrasonic probe, which are located outside and inside respectively.Each measurement site was divided into three measurements and the average value was taken, and the overall average value of the three averages of each site was taken as the final value.
Measured: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 (Week 1 after last treatment), Week 14 (Month 1 after last treatment), Week 22 (Month 3 after last treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start1 Jul 2024
- Primary completion1 Feb 2025
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BMIStudies 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
- Single group
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Medical Association
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Chengxin Li, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850246
- Sponsor's protocol ID
- 03010240620
- Status last verified
- Jun 2024
- First submitted
- 23 Feb 2025
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of High Frequency Electrocautery for Abdominal Fat Reduction
- ClinicalTrials.gov ID
- NCT06850246
- Acronym / sponsor ID
- 03010240620
- Conditions
- BMI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese Medical AssociationResearch network
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 27 Feb 2025 (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.
The goal of this clinical trial is to learn if the intervention of radiofrequency technology can help treat abdominal fat hypertrophy and skin laxity in adults. The main questions it aims to answer are
- Does radiofrequency technology lower the abdominal subcutaneous adipose tissue height by ultrasound measurement?
- Does radiofrequency technology improve abdominal circumference data and lower the number of times participants need to use a rescue inhaler.
Researchers will compare the treatment side to the non-treatment side to see if radiofrequency technology works to treat abdominal fat hypertrophy and skin laxity?
Participants will:
- Accept the treatment of radiofrequency technology every week for 10 weeks.
- Visit the clinic 1 month and 3 months after the treatment ends for checkups and tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| radiofrequency technology | Experimental | Device: treatment of radiofrequency technologyFirst, the frequency of 470 kHz was selected, and the CRT resistance probe was performed for deep fat management operation for 10 minutes, and then the CET capacitive mode 470 kHz was selected for superficial fat operation for 6 minutes. Then, select the 940 kHz frequency CET capacitance probe for epidermal tightening operation for 4 minutes. The temperature is set by the energy value. In CRT mode, the energy value is set to 70, and it can reach above 42 ℃ within one minute. In CET mode, the energy value setting is adjusted to 75. The operation mode is to gradually raise the temperature to the midline after partially increasing the temperature at the side of the waist. The technique is mainly to move in a circle and lift to the midline. |
| Placebo | Placebo comparator | Device: PlaceboUnder the condition that the machine is not turned on, the treatment is performed in the same operation time, mode and treatment area of the treatment group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Voluntarily sign the informed consent form;
- Age 18 to 65 years old (including 18 and 65 years old), male or female;
- The body mass index (BMI) is in the range of 22 ~ 35 (kg/m2) (including the cut-off value);
- Maintain a stable weight and lifestyle (including calorie intake and exercise) throughout the clinical study period and within 6 months after the end of the study;
- Non-pregnant and breastfeeding women who have no pregnancy plan and voluntarily take effective contraceptive measures during the screening period and the whole trial period, and have no sperm or egg donation plan.
Key exclusion criteria (11 listed)
- Patients who gained or lost more than 2.5 kg of weight during the study;
- Patients who have used weight loss drugs or participated in weight loss-related programs within 6 months of the start of the study;
- Have received or are about to receive surgery or liposuction in the abdomen, or have received lipolytic drugs injected in the abdomen, or have received abdominoplasty or cryo lipolysis;
- History of abdominal/waist-related trauma or scar;
- Patients with excessive accumulation of abdominal skin affecting the operation;
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 |
|---|---|---|
| treatment of radiofrequency technologyWhen operating, first select 470 kHz frequency, CRT resistance probe for deep fat management operation for 10 minutes, and then select CET capacitance mode 470 kHz for superficial fat operation for 6 minutes. Then, select the 940 kHz frequency CET capacitance probe for epidermal tightening operation for 4 minutes. The temperature is set by the energy value. In CRT mode, the energy value is set to 70, and it can reach above 42 ℃ within one minute. In CET mode, the energy value setting is adjusted to 75. The operation mode is to gradually raise the temperature to the midline after partially increasing the temperature at the side of the waist. The technique is mainly to move in a circle and lift to the midline. | Device | radiofrequency technology |
| PlaceboUnder the condition that the machine is not turned on, the treatment is performed in the same operation time, mode, and treatment area of the treatment group. | Device | Placebo |
Primary outcome
Height of abdominal subcutaneous adipose tissue
Time frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 (Week 1 after last treatment), Week 14 (Month 1 after last treatment), Week 22 (Month 3 after last treatment)
Ultrasound (GE LogiQ P6 ultrasound system, 132 GE Healthcare, Wauwatosa, WI) was used to measure the height of abdominal subcutaneous adipose tissue at four positions below the left and right abdomen three times respectively. A mold plate was designed to fix the ultrasound probe, centered on the umbilicus, and symmetrically symmetrically. Areas A and B are horizontal measurement of ultrasonic probe, which are located above and below the left/right abdomen respectively, and areas C and D are vertical measurement of ultrasonic probe, which are located outside and inside respectively.Each measurement site was divided into three measurements and the average value was taken, and the overall average value of the three averages of each site was taken as the final value.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treatment of radiofrequency technology in people with BMI, run by Chinese Medical Association at 1 site 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 5 inclusion and 11 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 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Height of abdominal subcutaneous adipose tissue (time frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 (Week 1 after last treatment), Week 14 (Month 1 after last treatment), Week 22 (Month 3 after last treatment)). 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 3 Mar 2025.