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
47 participants
INTERVENTIONAL
2020-01-28
2020-11-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Thighs circumference reduction
The subjects will be enrolled and treated once per week. Both legs will be treated consecutively. The therapy will be applied simultaneously.
BTL-899
Treatment with study device.
Saddlebags fat thickness reduction
The subjects will be enrolled and treated once per week. Both legs will be treated consecutively. The therapy will be applied consecutively too.
BTL-899
Treatment with study device.
Interventions
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BTL-899
Treatment with study device.
Eligibility Criteria
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Inclusion Criteria
* Visible excess of adipose tissue at the treatment sites (ARM 1 - thigh area; ARM 2 - saddlebags area).
* Subjects willing and able to abstain from partaking in any treatments other than the study procedure to promote body contouring and/or weight loss during study participation.
* No procedure for fat reduction (including cellulite treatment) in the last six months.
* Subjects willing and able to maintain his/her regular (pre-procedure) diet and exercise regimen without effecting a significant change of weight in either direction during study participation.
* Age between 21 and 70 years.
Exclusion Criteria
* Cardiovascular diseases
* Vascular diseases (such as chronic venous insufficiency, deep venous thrombosis, varicose veins, etc.)
* Femoral or inguinal hernia
* 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
* Unstable weight within the last 6 months (change in weight ± 3%)
* Previous body contouring or cellulite treatments in the thighs area in the last six months
* Any other disease or condition at the investigator's discretion
21 Years
70 Years
ALL
Yes
Sponsors
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BTL Industries Ltd.
INDUSTRY
Responsible Party
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Locations
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Aesthe Clinic
Sofia, , Bulgaria
Countries
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Other Identifiers
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BTL-899THI
Identifier Type: -
Identifier Source: org_study_id