OverweightNCT03545360
Safety and Efficacy of the BTL-703 Treatment for the Non-invasive Lipolysis
A study testing BTL-703 (Treatment group) in people with Overweight and Obesity, run by BTL Industries Ltd. at 1 site in Bulgaria.
Trial summary
The study will evaluate safety and efficacy of the BTL-703 device for the non-invasive lipolysis. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- BTL-703 (Treatment group)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteBulgaria
- Study dates
- 1 Mar 2018to 1 Jan 2019
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 22 years
- Voluntarily signed informed consent form
Who cannot join
- Implanted electronic device such as a cardiac pacemaker, bladder stimulator, spinal cord stimulator or electrodes for a myoelectric prosthesis, etc.
- Diabetics dependent on insulin or oral hypoglycemic medications
- Known cardiovascular disease such as arrhythmias, congestive heart failure
- Cardiac surgeries such as cardiac bypass, heart transplant surgery, pacemakers.
- Prior surgical interventions for body sculpting of thighs or buttocks such as liposuction
- Medical, physical or other contraindications for body sculpting/ weight loss
Show all 13Show fewer
- Current use of medication known to affect weight levels and/or cause bloating or swelling and for which abstinence during the course of study participation is not safe or medically prudent
- Any medical condition known to affect weight levels and/or to cause bloating or swelling
- Active infection, wound or other external trauma to the area to be treated
- Pregnant, breast feeding, or planning pregnant before the end of the study
- Serious mental health illness
- Active or recurrent cancer or current chemotherapy and/or radiation treatment
- Negative affection to heat
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site, 1 recruiting
- Recruiting
Aesthe Clinic
Sofia
Radina Denkova, MD, aestheclinic@abv.bg
Radina Denkova, MD
About this study
The study will evaluate safety and efficacy of the BTL-703 device for the non-invasive lipolysis.
- Conditions
- Overweight, Obesity
- Being tested
- BTL-703 (Treatment group)
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTL-703 (Treatment group)Device
Treatment with BTL-703 device
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Treated group of subjects, serves as its own control Receives: Device: BTL-703 (Treatment group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waist circumference reduction
The waist circumference measure will be conducted in accordance to the WHO STEPwise approach to surveillance (2008.) and NHLBI Obesity Education Initiative (2000.) recommendations. The waist circumference after the therapy will be compared to baseline.
Measured: 5 months
Secondary outcomes (4)
Serious adverse events following the treatment
Occurrence of serious adverse events will be followed throughout the whole study.
Measured: 5 months
Photo evaluation
Correct identification of the pre- and post-treatment photos by blinded evaluators.
Measured: 5 months
Subject Satisfaction
Subject Satisfaction Questionnaire will be given to subjects at every follow-up visit.
Measured: 5 months
Therapy discomfort
Subject's discomfort (pain) level after each treatment will be assessed using the Discomfort Questionnaire.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start1 Mar 2018
- Primary completion1 Dec 2018 (estimated)
- Study completion1 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BTL Industries Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545360
- Sponsor's protocol ID
- BTL-703-001
- Status last verified
- May 2018
- First submitted
- 28 Mar 2018
- Last updated
- 4 Jun 2018
- 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 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the BTL-703 Treatment for the Non-invasive Lipolysis
- ClinicalTrials.gov ID
- NCT03545360
- Acronym / sponsor ID
- BTL-703-001
- Conditions
- Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 Jan 2019 (estimated)
- First posted
- 4 Jun 2018 (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 study will evaluate safety and efficacy of the BTL-703 device for the non-invasive lipolysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: BTL-703 (Treatment group)Treated group of subjects, serves as its own control |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 22 years
- Voluntarily signed informed consent form
Key exclusion criteria (13 listed)
- Implanted electronic device such as a cardiac pacemaker, bladder stimulator, spinal cord stimulator or electrodes for a myoelectric prosthesis, etc.
- Diabetics dependent on insulin or oral hypoglycemic medications
- Known cardiovascular disease such as arrhythmias, congestive heart failure
- Cardiac surgeries such as cardiac bypass, heart transplant surgery, pacemakers.
- Prior surgical interventions for body sculpting of thighs or buttocks such as liposuction
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-703 (Treatment group)Treatment with BTL-703 device | Device | Treatment Group |
Primary outcome
Waist circumference reduction
Time frame: 5 months
The waist circumference measure will be conducted in accordance to the WHO STEPwise approach to surveillance (2008.) and NHLBI Obesity Education Initiative (2000.) recommendations. The waist circumference after the therapy will be compared to baseline.
4 secondary outcomes
Serious adverse events following the treatment
Time frame: 5 months
Photo evaluation
Time frame: 5 months
Subject Satisfaction
Time frame: 5 months
Therapy discomfort
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- 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.
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-703 (Treatment group) in people with Overweight and Obesity, 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 2 inclusion and 13 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 4 Jun 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Georgi Petkov (32 62 22 52 ext. +359, petkov@btlnet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Waist circumference reduction (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 4 Jun 2018.