Clinical Evaluation of the BTL-899 Device for Non-invasive Lipolysis on Human Fat Tissue (NCT03923855) | Clinical Trial Compass
CompletedNot Applicable
Clinical Evaluation of the BTL-899 Device for Non-invasive Lipolysis on Human Fat Tissue
Bulgaria8 participantsStarted 2019-05-01
Plain-language 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.
Who can participate
Age range21 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Electronic implants (such as cardiac pacemakers, defibrillators and neurostimulators)
* Cardiovascular diseases
* Disturbance of temperature or pain perception
* Pulmonary insufficiency
* Metal implants
* 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
* 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
…
What they're measuring
1
Histology Examination
Timeframe: 4 months
2
Evaluation of Satefy: Occurence of adverse events throughout the study