Fat BurnNCT05260164
Effect of BTL-899 Device for Non-invasive Lipolysis on Human Flanks
A study testing HIFEM+RF in people with Fat Burn, run by BTL Industries Ltd. at 1 site in Bulgaria.
Trial summary
This study will evaluate the clinical safety and the performance of the BTL-899 device (with its 899-AP-C-4 and 899-AP-C-5 applicators) during treatment of the flanks (also known as "love handles"). The study has a single-arm, open-label, interventional design. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Fat Burn
- What is being tested?
- HIFEM+RF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteBulgaria
- Study dates
- 11 Mar 2022to 30 Jan 2023
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body Mass Index (BMI) of 20 to 35 kg/m2.
- Visible excess of adipose tissue confirmed with pinch test at the flanks ("love handles") area.
- Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring and/or weight loss during study participation.
- Successful initial determination of the flanks' fat thickness by means of ultrasound.
- No procedure for fat reduction at the treated area in the last six months.
- Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting a significant change of weight in either direction during study participation.
- Age between 18 and 70 years.
Who cannot join
- Electronic implants (such as intrauterine device, cardiac pacemakers, defibrillators, and neurostimulators)
- Metal implants
- Drug pumps
- Malignant tumor
- Pulmonary insufficiency
- Injured or otherwise impaired muscles in the treatment area
Show all 24Show 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
- Graves' disease
- Scars, open lesions, and wounds at the treatment area
- Abdominal hernia
- Gynecological disease incl. inflammation in the pelvis
- Hip and rib cage trauma or recent surgery of those
- Previous liposuction in the treatment area in the last six months
- Unstable weight within the last 6 months (change in weight ± 3%)
- Previous body contouring or cellulite treatments in the flanks area in the last six months
- Any other disease or condition at the investigator's discretion
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site
Outpatient Practice for Specialized Medical Care - Individual practice for specialized medical dermatology care Mariya Genova MD
Plovdiv
About this study
This study will evaluate the clinical safety and the performance of the BTL-899 device (with its 899-AP-C-4 and 899-AP-C-5 applicators) during treatment of the flanks (also known as "love handles"). The study has a single-arm, open-label, interventional design. The subjects will be enrolled and assigned into one study arm and will be required to complete four (4) treatment visits.
Both flanks will be treated simultaneously for 30 minutes per session. The flanks' fat thickness reduction will be documented by ultrasound.
Read more
At the baseline visits health status will be assessed and, if needed, additional tests will be performed. Inclusion and exclusion criteria will be verified and informed consent will be signed.
The treatment administration phase consists of four (4) treatment visits, delivered 5 - 10 days apart.
At every treatment visit after the first, prior to the procedure, the participants will be assessed for adverse effects resulting from the previous treatment(s) with the BTL-899 device.
Safety measures will include documentation of adverse events (AE) during and after the procedures.
Follow-ups visits at 1 month and 3 months after the final treatment will be held.
- Conditions
- Fat Burn
- Being tested
- HIFEM+RF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIFEM+RFDevice
Combination of High-Intensity Focused Electromagnetic Field (HIFEM) and a high radio frequency (RF) field.
| Study group | Role | What they receive |
|---|---|---|
| HIFEM+RF | Experimental | The subjects will be enrolled and assigned into one study arm and will be required to complete four (4) treatment visits.
Both flanks will be treated simultaneously with the BTL-899 device for 30 minutes per session. Receives: Device: HIFEM+RF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of fat thickness in the flanks area evaluated by ultrasound
To gather clinical evidence that the BTL-899 device is able to induce non-invasive lipolysis when used on human flanks
Measured: 5 months
Secondary outcomes (2)
Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire
Assessment the safety of the BTL-899 device when used for non-invasive lipolysis of the flanks via questionnaires filled in by the participants following each therapy session. 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. The outcome will further be measured through the occurrence of adverse events or lack thereof.
Measured: 5 months
Evaluation of the participants' satisfaction with the therapy evaluated via standard questionnaires
Majority of the treated subjects to report satisfaction (level satisfied and higher) with the therapy.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start11 Mar 2022
- Primary completion30 Nov 2022
- Study completion30 Jan 2023
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
- 55 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
- NCT05260164
- Sponsor's protocol ID
- BTL-899_CTBG200
- Status last verified
- Apr 2023
- First submitted
- 18 Feb 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of BTL-899 Device for Non-invasive Lipolysis on Human Flanks
- ClinicalTrials.gov ID
- NCT05260164
- Acronym / sponsor ID
- BTL-899_CTBG200
- Conditions
- Fat Burn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 2 Mar 2022 (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 safety and the performance of the BTL-899 device (with its 899-AP-C-4 and 899-AP-C-5 applicators) during treatment of the flanks (also known as "love handles"). The study has a single-arm, open-label, interventional design. The subjects will be enrolled and assigned into one study arm and will be required to complete four (4) treatment visits.
Both flanks will be treated simultaneously for 30 minutes per session. The flanks' fat thickness reduction will be documented by ultrasound.
At the baseline visits health status will be assessed and, if needed, additional tests will be performed. Inclusion and exclusion criteria will be verified and informed consent will be signed.
The treatment administration phase consists of four (4) treatment visits, delivered 5 - 10 days apart.
At every treatment visit after the first, prior to the procedure, the participants will be assessed for adverse effects resulting from the previous treatment(s) with the BTL-899 device.
Safety measures will include documentation of adverse events (AE) during and after the procedures.
Follow-ups visits at 1 month and 3 months after the final treatment will be held.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIFEM+RF | Experimental | Device: HIFEM+RFThe subjects will be enrolled and assigned into one study arm and will be required to complete four (4) treatment visits. Both flanks will be treated simultaneously with the BTL-899 device for 30 minutes per session. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Body Mass Index (BMI) of 20 to 35 kg/m2.
- Visible excess of adipose tissue confirmed with pinch test at the flanks ("love handles") area.
- Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring and/or weight loss during study participation.
- Successful initial determination of the flanks' fat thickness by means of ultrasound.
- No procedure for fat reduction at the treated area in the last six months.
Key exclusion criteria (24 listed)
- Electronic implants (such as intrauterine device, 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 |
|---|---|---|
| HIFEM+RFCombination of High-Intensity Focused Electromagnetic Field (HIFEM) and a high radio frequency (RF) field. | Device | HIFEM+RF |
Primary outcome
Change of fat thickness in the flanks area evaluated by ultrasound
Time frame: 5 months
To gather clinical evidence that the BTL-899 device is able to induce non-invasive lipolysis when used on human flanks
2 secondary outcomes
Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire
Time frame: 5 months
Evaluation of the participants' satisfaction with the therapy evaluated via standard questionnaires
Time frame: 5 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 12 Apr 2023.
- 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 HIFEM+RF in people with Fat Burn, run by BTL Industries Ltd. at 1 site in Bulgaria.
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 24 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 12 Apr 2023. 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 Bulgaria. 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?
Change of fat thickness in the flanks area evaluated by ultrasound (time frame: 5 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 12 Apr 2023.