Fat BurnNCT04587804
Abdomen - Fat Reduction and Muscle Toning
A study testing rPMS+RF in people with Fat Burn, run by BTL Industries Ltd. at 2 sites in United States.
Trial summary
This study will evaluate the clinical efficacy and safety of a simultaneous treatment by repetitive pulse magnetic stimulation and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat. The study is a prospective multi-center open-label single-arm study. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fat Burn
- What is being tested?
- rPMS+RF
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Jun 2019to 15 Mar 2021
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 21 years
- Voluntarily signed informed consent form
- BMI ≤ 35 kg/m2
- Women of child-bearing potential are required to use birth control measures during the whole duration of the study
- Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation
- Subjects willing and able to maintain her regular (pre-procedure) diet and exercise regimen without affecting significant change in either direction during study participation
Who cannot join
- Electronic implants (such as cardiac pacemakers, defibrillators and neurostimulators)
- Metal implants
- Drug pumps
- Malignant tumour
- Pulmonary insufficiency
- Injured or otherwise impaired muscles
Show all 18Show fewer
- Cardiovascular diseases
- Disturbance of temperature or pain perception
- Hemorrhagic conditions
- Septic conditions and empyema
- Acute inflammations
- Systemic or local infection such as osteomyelitis and tuberculosis
- Contagious skin disease
- Elevated body temperature
- Pregnancy, postpartum period, nursing, and menstruation
- Intrauterine device (IUD)
- Swollen or neoplastic tissues, space occupying lesions or skin eruptions in the treatment area
- Basedow's disease
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Chicago Cosmetic Surgery and Dermatology
Chicago, Illinois, 60654
Skin Care Physicians of Georgia
Macon, Georgia, 31217
About this study
Official title: Abdominal Treatment With Simultaneous Application of Noninvasive Repetitive Pulse Magnetic Stimulation (rPMS) and Radiofrequency
This study will evaluate the clinical efficacy and safety of a simultaneous treatment by repetitive pulse magnetic stimulation and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat. The study is a prospective multi-center open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete three (3) treatment visits and two to three follow-up visits. All of the study subjects will receive the treatment with the subject device.
Read the detailed description
This study will evaluate the clinical efficacy and safety of a simultaneous treatment by repetitive pulse magnetic stimulation and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat. The study is a prospective multi-center open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete three (3) treatment visits and two to three follow-up visits. All of the study subjects will receive the treatment with the subject device.
At the baseline visit MRI will be performed, subject's weight and waist circumference will be recorded. Photos of the treated area will be taken.
The treatment administration phase will consist of three (3) treatments, delivered once a week. The applicator will be applied over umbilicus and visible muscle contractions along with heating of the subcutaneous fat will be induced by the device.
At the last therapy visit, the subject's weight and waist circumference will be recorded, and photos of the treated area will be taken. In addition, subjects will receive Subject Satisfaction Questionnaire to fill in.
Safety measures will include documentation of adverse events (AE) including subject's experience of pain or discomfort after each procedure. Following each treatment administration and at all of the follow-up visits, subjects will be checked for immediate post-procedure adverse event assessment.
During the post-procedure visits (at 1-month and 3-month follow-up visits), the subjects will undergo MRI scanning. Also, subject's satisfaction will be noted and weight with waist circumference will be recorded. Photographs of the treated area will be taken. There will be an option of a 6-months follow-up visit, according to subject's availability.
- Conditions
- Fat Burn
- Being tested
- rPMS+RF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rPMS+RFDevice
The treatment administration phase will consist of three (3) treatments, delivered once a week. The applicator of the device will be applied over umbilicus and visible muscle contractions along with heating of the subcutaneous fat will be induced by the device.
| Study group | Role | What they receive |
|---|---|---|
| Abdominal Toning and Reduction of Subcutaneous Fat | Experimental | simultaneous treatment by repetitive pulse magnetic stimulation and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat Receives: Device: rPMS+RF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of change in adipose and muscular layer thickness between pre-treatment and post-treatment based on MRI scans
MRI will be conducted at the baseline visit and all follow-up visits. The imaging will be conducted at the same surface area each time.
Hospital-grade MRI device will be used to scan abdominal area of each subject. The MRI scan without any contrast agent will be performed, with the scanned body segment determined by vertebrae T12 and S1. Lateral cuts from 5 cm below the umbilicus and 5 cm above the umbilicus will be evaluated for the thickness of muscle and subcutaneous adipose tissue.
Measured: 4 months
Evaluation of change in adipose layer thickness between pre-treatment and post-treatment based on waist circumference measurements
Waist circumference measure will be conducted at the baseline visit, after last treatment and during follow-up visits.
The waist circumference measure will be made at the top of the subject's iliac crest, with the tape held snugly, but not constricting, and at a level parallel to the floor. For the measurement, a stretch-resistant tape will be used.
During the measuring, subject will stand with arms at the side, feet positioned close together, and weight evenly distributed across the feet. The subject will be instructed to relax and take a few deep, natural breaths before the actual measurement is made. The subjects will be measured in underwear only, after voiding the bladder.
Measured: 4 months
Secondary outcomes (2)
Evaluation of subject's satisfaction with the treatment using the Subject Satisfaction Questionnaire
The 5-point Likert scale Satisfaction questionnaire will be used to evaluate the participant's satisfaction with the therapy outcome with answer "Strongly agree" being the most positive outcome and "Strongly disagree" the most negative. Subject satisfaction will be assessed after the last therapy visit and during the follow-up visits.
Measured: 7 months
Safety of the device measured via the occurrence of adverse events or lack thereof
The occurrence of adverse events will be followed throughout the whole study.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start17 Jun 2019
- Primary completion9 Jun 2020
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fat BurnStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- BTL Industries Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587804
- Sponsor's protocol ID
- BTL-703_100
- Status last verified
- Mar 2021
- First submitted
- 8 Oct 2020
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Treatment With Simultaneous Application of Noninvasive Repetitive Pulse Magnetic Stimulation (rPMS) and Radiofrequency
- ClinicalTrials.gov ID
- NCT04587804
- Acronym / sponsor ID
- BTL-703_100
- Conditions
- Fat Burn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 9 Jun 2020 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 14 Oct 2020 (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 study will evaluate the clinical efficacy and safety of a simultaneous treatment by repetitive pulse magnetic stimulation and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat. The study is a prospective multi-center open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete three (3) treatment visits and two to three follow-up visits. All of the study subjects will receive the treatment with the subject device.
Detailed description
This study will evaluate the clinical efficacy and safety of a simultaneous treatment by repetitive pulse magnetic stimulation and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat. The study is a prospective multi-center open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete three (3) treatment visits and two to three follow-up visits. All of the study subjects will receive the treatment with the subject device.
At the baseline visit MRI will be performed, subject's weight and waist circumference will be recorded. Photos of the treated area will be taken.
The treatment administration phase will consist of three (3) treatments, delivered once a week. The applicator will be applied over umbilicus and visible muscle contractions along with heating of the subcutaneous fat will be induced by the device.
At the last therapy visit, the subject's weight and waist circumference will be recorded, and photos of the treated area will be taken. In addition, subjects will receive Subject Satisfaction Questionnaire to fill in.
Safety measures will include documentation of adverse events (AE) including subject's experience of pain or discomfort after each procedure. Following each treatment administration and at all of the follow-up visits, subjects will be checked for immediate post-procedure adverse event assessment.
During the post-procedure visits (at 1-month and 3-month follow-up visits), the subjects will undergo MRI scanning. Also, subject's satisfaction will be noted and weight with waist circumference will be recorded. Photographs of the treated area will be taken. There will be an option of a 6-months follow-up visit, according to subject's availability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abdominal Toning and Reduction of Subcutaneous Fat | Experimental | Device: rPMS+RFsimultaneous treatment by repetitive pulse magnetic stimulation and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 21 years
- Voluntarily signed informed consent form
- BMI ≤ 35 kg/m2
- Women of child-bearing potential are required to use birth control measures during the whole duration of the study
- Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring during study participation
Key exclusion criteria (18 listed)
- Electronic implants (such as cardiac pacemakers, defibrillators and neurostimulators)
- Metal implants
- Drug pumps
- Malignant tumour
- Pulmonary insufficiency
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 |
|---|---|---|
| rPMS+RFThe treatment administration phase will consist of three (3) treatments, delivered once a week. The applicator of the device will be applied over umbilicus and visible muscle contractions along with heating of the subcutaneous fat will be induced by the device. | Device | Abdominal Toning and Reduction of Subcutaneous Fat |
Primary outcome
Evaluation of change in adipose and muscular layer thickness between pre-treatment and post-treatment based on MRI scans
Time frame: 4 months
MRI will be conducted at the baseline visit and all follow-up visits. The imaging will be conducted at the same surface area each time. Hospital-grade MRI device will be used to scan abdominal area of each subject. The MRI scan without any contrast agent will be performed, with the scanned body segment determined by vertebrae T12 and S1. Lateral cuts from 5 cm below the umbilicus and 5 cm above the umbilicus will be evaluated for the thickness of muscle and subcutaneous adipose tissue.
Evaluation of change in adipose layer thickness between pre-treatment and post-treatment based on waist circumference measurements
Time frame: 4 months
Waist circumference measure will be conducted at the baseline visit, after last treatment and during follow-up visits. The waist circumference measure will be made at the top of the subject's iliac crest, with the tape held snugly, but not constricting, and at a level parallel to the floor. For the measurement, a stretch-resistant tape will be used. During the measuring, subject will stand with arms at the side, feet positioned close together, and weight evenly distributed across the feet. The subject will be instructed to relax and take a few deep, natural breaths before the actual measurement is made. The subjects will be measured in underwear only, after voiding the bladder.
2 secondary outcomes
Evaluation of subject's satisfaction with the treatment using the Subject Satisfaction Questionnaire
Time frame: 7 months
Safety of the device measured via the occurrence of adverse events or lack thereof
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rPMS+RF in people with Fat Burn, run by BTL Industries Ltd. at 2 sites in United States.
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 6 inclusion and 18 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: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluation of change in adipose and muscular layer thickness between pre-treatment and post-treatment based on MRI scans (time frame: 4 months). The study lists 2 primary outcomes in all. 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 1 Apr 2021; AzTrials last refreshed its copy on 6 Nov 2026.