Fat BurnNCT04643275
Effect of BTL-899 Device for Non-invasive Lipolysis on Human Upper Arms
A study testing BTL-899 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 during the treatment of upper arms. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Fat Burn
- What is being tested?
- BTL-899
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBulgaria
- Study dates
- 15 Oct 2020to 2 Sep 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 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 at the treatment site
- 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.
- No procedure for fat reduction in the 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 the study participation.
Who cannot join
- Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
- Cardiovascular diseases
- Vascular diseases (such as chronic venous insufficiency, deep venous thrombosis, varicose veins, etc.)
- Disturbance of temperature or pain perception
- Pulmonary insufficiency
- Metal implants
Show all 21Show fewer
- Drug pumps
- Malignant tumor
- Hemorrhagic conditions
- Septic conditions and empyema
- Acute inflammations
- Systemic or local infection such as osteomyelitis and tuberculosis
- Contagious skin disease
- Elevated body temperature
- Pregnancy
- Breastfeeding
- Injured or otherwise impaired muscles in the arms
- Scars, open lesions, and wounds at the treatment area
- Basedow's disease
- Previous liposuction in the treatment area in the last six months
- Any other disease or condition at the investigator's discretion, e.g. dislocated shoulder or carpal tunnel syndrome than can pose danger to the patient or compromise the study
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the clinical safety and the performance of the BTL-899 device during the treatment of upper arms.
Read the detailed description
The aim of the study is to confirm the efficacy and the safety of the treatment. The efficacy (reduction of excess adipose tissue) will be assessed via correct identification of pre-treatment and 3-months follow-up images by at least two out of three independent blinded evaluators. The fat reduction will be also measured by means of ultrasound. Comfort and satisfaction will be assessed via standard questionnaires.
Safety measures will include documentation of adverse events (AE) during and after the procedures.
- 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 study device.
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive lipolysis of the upper arms | Experimental | The treatment administration phase consists of four (4) treatment visits, delivered 5- 10 - days apart. Each therapy session will last 30 minutes. Follow-ups visits at 1 month and 3 months after the final treatment will be held. Receives: Device: BTL-899 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Statistically significant reduction of fat thickness in the upper arms evaluated by photographs
To gather clinical evidence that the BTL-899 device is able to induce non-invasive lipolysis when used on upper arms. The primary efficacy outcome measure is a minimum 75% of the subjects' pre-treatment and 3-months follow-up images to be correctly identified by at least two of three independent blinded evaluators.
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 upper arms 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: 7 months
Evaluation of the participants' satisfaction with the therapy evaluated via standard questionnaires
Evaluation of the participants' satisfaction with the therapy and the results. ● Minimum 80% of 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 posted25 Nov 2020
- Study start15 Oct 2020
- Primary completion2 Aug 2021
- Study completion2 Sep 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
- 45 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
- NCT04643275
- Sponsor's protocol ID
- BTL-899A
- Status last verified
- Sep 2021
- First submitted
- 3 Nov 2020
- Last updated
- 9 Sep 2021
- 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 9 Sep 2021. 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 Upper Arms
- ClinicalTrials.gov ID
- NCT04643275
- Acronym / sponsor ID
- BTL-899A
- Conditions
- Fat Burn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 2 Aug 2021 (actual)
- Study completion
- 2 Sep 2021 (actual)
- First posted
- 25 Nov 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 safety and the performance of the BTL-899 device during the treatment of upper arms.
Detailed description
The aim of the study is to confirm the efficacy and the safety of the treatment. The efficacy (reduction of excess adipose tissue) will be assessed via correct identification of pre-treatment and 3-months follow-up images by at least two out of three independent blinded evaluators. The fat reduction will be also measured by means of ultrasound. Comfort and satisfaction will be assessed via standard questionnaires.
Safety measures will include documentation of adverse events (AE) during and after the procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-invasive lipolysis of the upper arms | Experimental | Device: BTL-899The treatment administration phase consists of four (4) treatment visits, delivered 5- 10 - days apart. Each therapy session will last 30 minutes. Follow-ups visits at 1 month and 3 months after the final treatment will be held. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Body Mass Index (BMI) of 20 to 35 kg/m2.
- Visible excess of adipose tissue at the treatment site
- 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.
- No procedure for fat reduction in the 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 the study participation.
Key exclusion criteria (21 listed)
- Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
- Cardiovascular diseases
- Vascular diseases (such as chronic venous insufficiency, deep venous thrombosis, varicose veins, etc.)
- Disturbance of temperature or pain perception
- 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 study device. | Device | Non-invasive lipolysis of the upper arms |
Primary outcome
Statistically significant reduction of fat thickness in the upper arms evaluated by photographs
Time frame: 5 months
To gather clinical evidence that the BTL-899 device is able to induce non-invasive lipolysis when used on upper arms. The primary efficacy outcome measure is a minimum 75% of the subjects' pre-treatment and 3-months follow-up images to be correctly identified by at least two of three independent blinded evaluators.
2 secondary outcomes
Evaluation of the Therapy's Safety Measured Via Therapy Comfort Questionnaire
Time frame: 7 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 9 Sep 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.
1 site 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 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 5 inclusion and 21 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 9 Sep 2021. 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?
Statistically significant reduction of fat thickness in the upper arms evaluated by photographs (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 9 Sep 2021.