Clinical Evaluation of the BTL-899 Device for Non-invasive Lipolysis on Human Fat Tissue
NCT ID: NCT03923855
Last Updated: 2019-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
8 participants
INTERVENTIONAL
2019-05-01
2019-10-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BTL-899 Therapy Arm
BTL-899
BTL-899 therapy
Interventions
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BTL-899
BTL-899 therapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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
21 Years
60 Years
ALL
Yes
Sponsors
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BTL Industries Ltd.
INDUSTRY
Responsible Party
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Locations
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Dr. Denkova Dermatology
Sofia, , Bulgaria
Countries
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Other Identifiers
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899-H1
Identifier Type: -
Identifier Source: org_study_id