Non-invasive Lipolysis and Improvement of Muscle Tone in Lateral Abdomen
Completed · Not applicable
Conditions studied: Fat Burn
In brief
This study will evaluate the clinical efficacy and performance of the BTL-899 device for changes in subcutaneous fat and muscle tissue in the lateral abdomen region (also referred to as flanks or "love handles"). The study is a prospective, multi-center, open-label, single-arm study. The subjects will be enrolled and assigned into a single study group. Subjects will be required to complete four (4) treatment visits and two follow-up visits. All of the study subjects will receive the treatment with the subject device.
Key facts
- Study ID
- NCT05540080
- Run by
- BTL Industries Ltd.
- People needed
- 46
- Starts
- 2022-06-10
- Expected to finish
- 2023-10-11
- Last updated by the study team
- 2024-04-26
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age 22 years and older
- Voluntarily signed an 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 their regular (pre-procedure) diet and exercise regimen without affecting significant change in either direction during study participation
You may not qualify if…
- Electronic implants (such as cardiac pacemakers, defibrillators, and neurostimulators)
- Metal implants
- Drug pumps
- Malignant tumor
- Pulmonary insufficiency
- Injured or otherwise impaired muscles
- Cardiovascular diseases
- Disturbance of temperature or pain perception
- Hemorrhagic conditions
- Septic conditions and empyema
- Acute inflammations
- Systemic or local infection such as osteomyelitis and tuberculosis
- Contagious skin disease
- Elevated body temperature
- Pregnancy, postpartum period, nursing, and menstruation
- A metal-containing intrauterine device (IUD)
- Swollen or neoplastic tissues, space-occupying lesions or skin eruptions in the treatment area
- Graves' disease
Where it is running
- Laser & Skin Surgery Center of Northern California — Sacramento, California, United States
- AboutSkin Research, LLC — Greenwood Village, Colorado, United States
- Georgia Plastic & Reconstructive Surgery — Marietta, Georgia, United States
- Chicago Cosmetic Surgery and Dermatology — Chicago, Illinois, United States
- New Jersey Plastic Surgery (NJPS) — Montclair, New Jersey, United States
- Integrated Aesthetics — Spring, Texas, United States
Full record on ClinicalTrials.gov
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