Improvement of Abdomen AppearanceNCT03270150
Effect of the BTL-899 Therapy for Non-invasive Lipolysis and Circumference Reduction of Abdomen
A study testing BTL-899 in people with Improvement of Abdomen Appearance, run by BTL Industries Ltd. at 1 site in Bulgaria.
Trial summary
The study is a prospective open-label single-arm study that includes three treatment procedures and four follow-up visits. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Improvement of Abdomen Appearance
- 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
- 40 participants
- Where
- 1 siteBulgaria
- Study dates
- 1 Sep 2017to 3 Oct 2018
- 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 ≥ 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 his/her regular (pre-procedure) diet and exercise regimen without effecting significant change in either direction during study participation
Who cannot join
- Cardiac pacemakers
- Cardiovascular diseases
- Implanted defibrillators, implanted neurostimulators
- Electronic implants
- Disturbance of temperature or pain perception
- Pulmonary insufficiency
Show all 24Show fewer
- Metal implants
- Drug pumps
- Malignant tumor
- Hemorrhagic conditions
- Septic conditions and empyema
- Acute inflammations
- Systemic or local infection such as osteomyelitis and tuberculosis
- Contageous skin disease
- Elevated body temperature
- Pregnancy
- Breastfeeding
- Injured or otherwise impaired muscles
- Scars, open lesions and wounds at the treatment area
- Basedow's disease
- Previous liposuction in the treatment area in the last six months
- Abdominal wall diastasis
- Unstable weight within the last 6 months
- Previous body contouring treatments in the abdomen area in the last three months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Safety and Efficacy of the BTL-899 Device for Non-invasive Lipolysis and Circumference Reduction of Abdomen
The study is a prospective open-label single-arm study that includes three treatment procedures and four follow-up visits.
Read the detailed description
This study will evaluate the clinical efficacy and safety of the BTL-899 device for non-invasive lipolysis and circumference reduction of abdomen. The study is a prospective open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will complete three (3) treatment visits and will be invited to four (4) follow-up visits 1, 2, 3 and 6-months after the final treatment. 6-months follow-up visit is the optional one.
- Conditions
- Improvement of Abdomen Appearance
- 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
BTL-899
| Study group | Role | What they receive |
|---|---|---|
| BTL-899 Therapy Arm | Experimental | BTL-899 therapy, 3 therapies Receives: Device: BTL-899 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the BTL-899 treatment for abdomen circumference reduction after the final follow-up visit
Evaluation of change in abdomen circumference using tape measurements in cm at the final follow-up visit.
Measured: 4 months
Occurrence of adverse events
The occurrence of adverse events will be followed throughout the whole study.
Measured: 7 months
Secondary outcomes (5)
Efficacy of BTL-899 treatment for fat and circumference reduction in abdomen, as assessed by two blinded evaluators
Evaluation of photographs before and after the treatment.
Measured: 4 months
Efficacy of the BTL-899 treatment for abdomen circumference reduction
Evaluation of change in abdomen circumference using tape measurements in cm at all study visits after the first therapy.
Measured: 4 months
Ultrasound imaging
Evaluation of ultrasound images.
Measured: 4 months
Subject's satisfaction with study treatment
Subject's satisfaction with the therapy results evaluated through the Subject Satisfaction Questionnaire (5-point scale).
Measured: 4 months
Therapy comfort during the study treatment.
Therapy comfort during the treatment evaluated through the Therapy Comfort Questionnaire (10-point scale).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start1 Sep 2017
- Primary completion19 Sep 2018
- Study completion3 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Improvement of Abdomen AppearanceStudies 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
- 40 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
- NCT03270150
- Sponsor's protocol ID
- BTL-899L
- Status last verified
- Apr 2023
- First submitted
- 30 Aug 2017
- Last updated
- 12 Apr 2023
- Results posted
- 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
- Evaluation of Safety and Efficacy of the BTL-899 Device for Non-invasive Lipolysis and Circumference Reduction of Abdomen
- ClinicalTrials.gov ID
- NCT03270150
- Acronym / sponsor ID
- BTL-899L
- Conditions
- Improvement of Abdomen Appearance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 19 Sep 2018 (actual)
- Study completion
- 3 Oct 2018 (actual)
- First posted
- 1 Sep 2017 (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 is a prospective open-label single-arm study that includes three treatment procedures and four follow-up visits.
Detailed description
This study will evaluate the clinical efficacy and safety of the BTL-899 device for non-invasive lipolysis and circumference reduction of abdomen. The study is a prospective open-label single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will complete three (3) treatment visits and will be invited to four (4) follow-up visits 1, 2, 3 and 6-months after the final treatment. 6-months follow-up visit is the optional one.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BTL-899 Therapy Arm | Experimental | Device: BTL-899BTL-899 therapy, 3 therapies |
Who may qualify
- Ages
- 22 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 (24 listed)
- Cardiac pacemakers
- Cardiovascular diseases
- Implanted defibrillators, implanted neurostimulators
- Electronic implants
- Disturbance of temperature or pain perception
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-899BTL-899 | Device | BTL-899 Therapy Arm |
Primary outcome
Efficacy of the BTL-899 treatment for abdomen circumference reduction after the final follow-up visit
Time frame: 4 months
Evaluation of change in abdomen circumference using tape measurements in cm at the final follow-up visit.
Occurrence of adverse events
Time frame: 7 months
The occurrence of adverse events will be followed throughout the whole study.
5 secondary outcomes
Efficacy of BTL-899 treatment for fat and circumference reduction in abdomen, as assessed by two blinded evaluators
Time frame: 4 months
Efficacy of the BTL-899 treatment for abdomen circumference reduction
Time frame: 4 months
Ultrasound imaging
Time frame: 4 months
Subject's satisfaction with study treatment
Time frame: 4 months
Therapy comfort during the study treatment.
Time frame: 1 month
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
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 Improvement of Abdomen Appearance, 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 6 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?
Efficacy of the BTL-899 treatment for abdomen circumference reduction after the final follow-up visit (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 12 Apr 2023.