Unwanted Abdomen Fat Clinical Trial
Official title:
Clinical Study to Evaluate the Performances of Modified VelaShape and the Performance of Contour I V3 Devices for Abdominal Fat Reduction vs. Control
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.
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