Improvement of Abdomen AppearanceNCT04000945
Effect of the BTL-899 Therapy for Non-invasive Lipolysis and Circumference Reduction of Abdomen When Compared to a Sham Treatment
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 single-blinded two-arms 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?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBulgaria
- Study dates
- 3 Dec 2018to 31 Dec 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 > 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 When Compared to a Sham Treatment
The study is a prospective single-blinded two-arms 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 single-blinded two-arms study. The subjects will be enrolled and assigned into a two study groups. All 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, Sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTL-899Device
Treatment with BTL-899 device, 3 therapies
ShamDevice
Sham treatment with BTL-899 device, 3 visits
| Study group | Role | What they receive |
|---|---|---|
| BTL-899 Therapy Arm | Experimental | Not described Receives: Device: BTL-899 |
| Sham Arm | Sham comparator | Not described Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the BTL-899 treatment for change in abdominal circumference
Comparison of change in abdominal circumference at the final follow-up visit between two study groups.
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 abdominal fat and circumference reduction, as assessed by two blinded evaluators
Evaluation of aesthetic improvement achieved by abdominal fat and circumference reduction using photographs before and after the treatment.
Measured: 4 months
Efficacy of the BTL-899 treatment for change in abdominal circumference
Comparison of change in abdominal circumference at all study visits after the first therapy between two study groups.
Measured: 4 months
Efficacy of the BTL-899 treatment for abdominal fat reduction
Comparison of fat reduction between two study groups using 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 posted27 Jun 2019
- Study start3 Dec 2018
- Primary completion3 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 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
- NCT04000945
- Sponsor's protocol ID
- BTL-899S
- Status last verified
- Jun 2019
- First submitted
- 25 Jun 2019
- Last updated
- 27 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. 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 When Compared to a Sham Treatment
- ClinicalTrials.gov ID
- NCT04000945
- Acronym / sponsor ID
- BTL-899S
- Conditions
- Improvement of Abdomen Appearance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Dec 2018 (actual)
- Primary completion
- 3 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 27 Jun 2019 (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 single-blinded two-arms 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 single-blinded two-arms study. The subjects will be enrolled and assigned into a two study groups. All 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BTL-899 Therapy Arm | Experimental | Device: BTL-899 |
| Sham Arm | Sham comparator | Device: Sham |
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-899Treatment with BTL-899 device, 3 therapies | Device | BTL-899 Therapy Arm |
| ShamSham treatment with BTL-899 device, 3 visits | Device | Sham Arm |
Primary outcome
Efficacy of the BTL-899 treatment for change in abdominal circumference
Time frame: 4 months
Comparison of change in abdominal circumference at the final follow-up visit between two study groups.
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 abdominal fat and circumference reduction, as assessed by two blinded evaluators
Time frame: 4 months
Efficacy of the BTL-899 treatment for change in abdominal circumference
Time frame: 4 months
Efficacy of the BTL-899 treatment for abdominal fat reduction
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
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: status not confirmed, as of the sponsor's last update on 27 Jun 2019. 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. 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?
Results are not available in the source record.
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 change in abdominal circumference (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 27 Jun 2019.