Fat BurnNCT04587986
rPMS and Radiofrequency for Abdominal Toning and Reduction of Subcutaneous Fat
A study testing BTL-899 in people with Fat Burn, run by BTL Industries Ltd. at 3 sites in United States.
Trial summary
This study will evaluate the clinical efficacy and safety of a simultaneous treatment by high power magnet and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat. The study is a prospective multi-center single-blinded sham-controlled 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?
- BTL-899
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Jul 2019to 16 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
- 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 tumor
- 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
3 sites in 1 country.
United States3 sites
Maryland Laser Skin and Vein Institute
Hunt Valley, Maryland, 21030
JUVA Skin & Laser Center
New York, New York, 10022
Julene B. Samuels
River Bluff, Kentucky, 40059
About this study
Official title: Efficacy of Simultaneous Application of Noninvasive Repetitive Pulse Magnetic Stimulation (rPMS) and Radiofrequency for Abdominal Toning and Reduction of Subcutaneous Fat: Single-Blind Randomized Sham-Controlled Trial
This study will evaluate the clinical efficacy and safety of a simultaneous treatment by high power magnet and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat. The study is a prospective multi-center single-blinded sham-controlled study. The subjects will be enrolled and assigned into two study groups; active and sham group. Subjects of both groups will be required to complete three (3) treatment visits and two to three follow-up visits.
Read the detailed description
This study will evaluate the clinical efficacy and safety of a simultaneous treatment by high power magnet and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat. The study is a prospective multi-center single-blinded sham-controlled study. The subjects will be enrolled and assigned into two study groups; active and sham group. Subjects of both groups will be required to complete three (3) treatment visits and two to three follow-up visits.
At the baseline visit, ultrasound imaging will be performed; the subject's weight and waist circumference will be recorded. Photos of the treated area will be taken.
The treatment administration phase in both study groups will consist of three (3) treatments, delivered once a week. The applicator of BTL-703 will be applied over the umbilicus. The active group will receive treatment with intensities of a magnetic field and radiofrequency energy just below the patient's tolerance threshold. The device will induce visible muscle contractions along with heating of the subcutaneous fat. The sham group will receive a treatment with the intensities of the magnetic field and radiofrequency energy set to 5% of the maximum device output.
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 the 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 ultrasound imaging. Also, the 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
- BTL-899
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTL-899Device
Treatment with intensities of a magnetic field and radiofrequency energy just below the patient's tolerance threshold.
| Study group | Role | What they receive |
|---|---|---|
| Abdominal Toning and Reduction of Subcutaneous Fat | Experimental | The treatment administration phase will consist of three (3) treatments, delivered once a week. The applicator of BTL-703 will be applied over the umbilicus. The active group will receive treatment with intensities of a magnetic field and radiofrequency energy just below the patient's tolerance threshold. The device will induce visible muscle contractions along with heating of the subcutaneous fat. Receives: Device: BTL-899 |
| Sham control | Sham comparator | The treatment administration phase will also consist of three (3) treatments, delivered once a week. The sham group will receive a treatment with the intensities of the magnetic field and radiofrequency energy set to 5% of the maximum device output. Receives: Device: BTL-899 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in fat and muscle thickness in the abdominal area measured via ultrasound.
To gather clinical evidence on the effectiveness of the combined treatment for abdominal toning and subcutaneous fat reduction through changes in abdominal tissues, measured via ultrasound and comparison of active and sham groups. The changes will be considered statistically significant where p-value <0.05.
Measured: 7 months
Secondary outcomes (2)
Patient's satisfaction with study treatment measured via questionnaires
To determine the patient's satisfaction with study treatment for non-invasive aesthetic improvement of the abdomen. The 5-point Likert scale Satisfaction questionnaire will be used to evaluate the participant's satisfaction with the therapy outcome. Subject satisfaction will be assessed after the last therapy visit and during the follow-up visits.
Measured: 7 months
Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire
The outcome will further be measured through the occurrence of adverse events or lack thereof. On Numerical Analog Scale (0-10), where 0 represents 'no pain' and 10 represents 'worst possible pain' select the level of pain experienced during the treatment.
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 start30 Jul 2019
- Primary completion16 Jun 2020
- Study completion16 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 67 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
- NCT04587986
- Sponsor's protocol ID
- BTL-703_200
- Status last verified
- Mar 2021
- First submitted
- 6 Oct 2020
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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
- Efficacy of Simultaneous Application of Noninvasive Repetitive Pulse Magnetic Stimulation (rPMS) and Radiofrequency for Abdominal Toning and Reduction of Subcutaneous Fat: Single-Blind Randomized Sham-Controlled Trial
- ClinicalTrials.gov ID
- NCT04587986
- Acronym / sponsor ID
- BTL-703_200
- Conditions
- Fat Burn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 16 Jun 2020 (actual)
- Study completion
- 16 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 high power magnet and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat. The study is a prospective multi-center single-blinded sham-controlled study. The subjects will be enrolled and assigned into two study groups; active and sham group. Subjects of both groups will be required to complete three (3) treatment visits and two to three follow-up visits.
Detailed description
This study will evaluate the clinical efficacy and safety of a simultaneous treatment by high power magnet and radiofrequency energy for toning of abdomen and reduction of subcutaneous fat. The study is a prospective multi-center single-blinded sham-controlled study. The subjects will be enrolled and assigned into two study groups; active and sham group. Subjects of both groups will be required to complete three (3) treatment visits and two to three follow-up visits.
At the baseline visit, ultrasound imaging will be performed; the subject's weight and waist circumference will be recorded. Photos of the treated area will be taken.
The treatment administration phase in both study groups will consist of three (3) treatments, delivered once a week. The applicator of BTL-703 will be applied over the umbilicus. The active group will receive treatment with intensities of a magnetic field and radiofrequency energy just below the patient's tolerance threshold. The device will induce visible muscle contractions along with heating of the subcutaneous fat. The sham group will receive a treatment with the intensities of the magnetic field and radiofrequency energy set to 5% of the maximum device output.
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 the 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 ultrasound imaging. Also, the 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdominal Toning and Reduction of Subcutaneous Fat | Experimental | Device: BTL-899The treatment administration phase will consist of three (3) treatments, delivered once a week. The applicator of BTL-703 will be applied over the umbilicus. The active group will receive treatment with intensities of a magnetic field and radiofrequency energy just below the patient's tolerance threshold. The device will induce visible muscle contractions along with heating of the subcutaneous fat. |
| Sham control | Sham comparator | Device: BTL-899The treatment administration phase will also consist of three (3) treatments, delivered once a week. The sham group will receive a treatment with the intensities of the magnetic field and radiofrequency energy set to 5% of the maximum device output. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
- Metal implants
- Drug pumps
- Malignant tumor
- 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 |
|---|---|---|
| BTL-899Treatment with intensities of a magnetic field and radiofrequency energy just below the patient's tolerance threshold. | Device | Abdominal Toning and Reduction of Subcutaneous Fat, Sham control |
Primary outcome
Changes in fat and muscle thickness in the abdominal area measured via ultrasound.
Time frame: 7 months
To gather clinical evidence on the effectiveness of the combined treatment for abdominal toning and subcutaneous fat reduction through changes in abdominal tissues, measured via ultrasound and comparison of active and sham groups. The changes will be considered statistically significant where p-value <0.05.
2 secondary outcomes
Patient's satisfaction with study treatment measured via questionnaires
Time frame: 7 months
Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire
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.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BTL-899 in people with Fat Burn, run by BTL Industries Ltd. at 3 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 5 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 3 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. 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?
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?
Changes in fat and muscle thickness in the abdominal area measured via ultrasound. (time frame: 7 months). 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.