Prospective, 2-arm, clinical study for the evaluation of the VelaShape device and Contour I V3 device for non-invasive fat reduction vs. control. All study subjects, who are scheduled for abdominoplasty, will undergo one treatment with VelaShape or Contour I V3 device. Each arm will be treated with a different device: Arm 1: subject will treated with VelaShape device Arm 2: subject will treated with Contour I V3 device
Eligible subjects will undergo one treatment on one abdominal subarea. Another abdominal subarea will remain without treatment and will serve as a control. Biopsies from treated and untreated areas will be harvested during abdominoplasty and cultured.. Treatment with VelaShape will be performed to arm 1, and treatment with Contour I V3 will be performed to arm 2, according to the study protocol. Each arm will be divided into 6 sub-groups, according to the following time interval between VelaShape or UltraShape treatment to surgery: Sub-group 1: Surgery immediately after treatment Sub-group 2: Surgery 10 days after treatment Sub-group 3: Surgery 20 days after treatment Sub-group 4: Surgery 30 days after treatment Sub-group 5: Surgery 60 days after treatment Sub-group 6: Surgery 90 days after treatment Each Sub-group contains up to 2 subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
24
Modified VelaShape radiofrequency device for non invasive fat reduction treatment.
Contour I V3 device are non invasive for fat reduction.
Rabin Medical Center - Beilinson Hospital
Petah Tikva, Israel
RECRUITINGhistology following VelaShape treatment
Evaluate abdominal fat reduction post VelaShape treatment vs.control
Time frame: day 10 up to 90 days
Histology following Contour I V3 treatment
Evaluate Abdominal fat reduction post Contour I V3 treatment vs. control
Time frame: day 10 up to 90 days
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