Improvement of Abdomen AppearanceNCT03923855
Clinical Evaluation of the BTL-899 Device for Non-invasive Lipolysis on Human Fat Tissue
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 subjects will be enrolled and assigned to a single study group. They will be required to complete two treatment visits and come for a biopsy procedure. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy 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
- 8 participants
- Where
- 1 siteBulgaria
- Study dates
- 1 May 2019to 7 Oct 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age above 21 years and below 60 years
- Voluntarily signing of the informed consent form
- Women of child-bearing potential are required to use birth control measures during the whole duration of the study
- Eligibility to fat tissue biopsy at surgeon discretion, incl. at least 3-4 cm pinchable fat in the abdominal area
- Subjects willing and able to abstain from partaking in any 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
- Electronic implants (such as cardiac pacemakers, defibrillators and neurostimulators)
- Cardiovascular diseases
- Disturbance of temperature or pain perception
- Pulmonary insufficiency
- Metal implants
- Drug pumps
Show all 24Show fewer
- 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
- 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 (change in weight ± 3%)
- Previous body contouring treatments in the abdomen area in the last three months
- Any disease or condition contradicting the fat tissue biopsy at the surgeon discretion
- Any disease or condition that may compromise the histologic observation at the pathologist discretion
Trial locations and contacts
1 site in 1 country.
About this study
The subjects will be enrolled and assigned to a single study group. They will be required to complete two treatment visits and come for a biopsy procedure.
- 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 therapy
| Study group | Role | What they receive |
|---|---|---|
| BTL-899 Therapy Arm | Experimental | Not described Receives: Device: BTL-899 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histology Examination
Histological examination of the fat tissue after BTL-899 treatment at various days after the procedure
Measured: 4 months
Evaluation of Satefy: Occurence of adverse events throughout the study
Following the occurence of adverse events throughout the study.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start1 May 2019
- Primary completion17 Sep 2019
- Study completion7 Oct 2019
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
- 8 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
- NCT03923855
- Sponsor's protocol ID
- 899-H1
- Status last verified
- Dec 2019
- First submitted
- 18 Apr 2019
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the BTL-899 Device for Non-invasive Lipolysis on Human Fat Tissue
- ClinicalTrials.gov ID
- NCT03923855
- Acronym / sponsor ID
- 899-H1
- Conditions
- Improvement of Abdomen Appearance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 May 2019 (actual)
- Primary completion
- 17 Sep 2019 (actual)
- Study completion
- 7 Oct 2019 (actual)
- First posted
- 23 Apr 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 subjects will be enrolled and assigned to a single study group. They will be required to complete two treatment visits and come for a biopsy procedure.
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-899 |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age above 21 years and below 60 years
- Voluntarily signing of the informed consent form
- Women of child-bearing potential are required to use birth control measures during the whole duration of the study
- Eligibility to fat tissue biopsy at surgeon discretion, incl. at least 3-4 cm pinchable fat in the abdominal area
- Subjects willing and able to abstain from partaking in any procedure to promote body contouring during study participation
Key exclusion criteria (24 listed)
- Electronic implants (such as cardiac pacemakers, defibrillators and neurostimulators)
- Cardiovascular diseases
- Disturbance of temperature or pain perception
- Pulmonary insufficiency
- Metal implants
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 therapy | Device | BTL-899 Therapy Arm |
Primary outcome
Histology Examination
Time frame: 4 months
Histological examination of the fat tissue after BTL-899 treatment at various days after the procedure
Evaluation of Satefy: Occurence of adverse events throughout the study
Time frame: 4 months
Following the occurence of adverse events throughout the study.
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 20 Dec 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: finished, as of the sponsor's last update on 20 Dec 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. 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?
Histology Examination (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 20 Dec 2019; AzTrials last refreshed its copy on 7 Nov 2026.