VelaShape and Contour I V3 for Abdominal Fat Reduction vs. Control (NCT02553278) | Clinical Trial Compass
UnknownNot Applicable
VelaShape and Contour I V3 for Abdominal Fat Reduction vs. Control
Israel24 participantsStarted 2016-01-10
Plain-language summary
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
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Signed informed consent to participate in the study.
✓. Scheduled date for surgery (abdominoplasty).
✓. Agree to provide samples for histology from the abdominoplasty.
✓. Female and male subjects, between 18 to 60 years of age at the time of enrollment
✓. Fitzpatrick Skin Type I to VI.
✓. For Contour I V3 treatment only: Abdominal fat thickness of at least 1.5 cm (measured by calibrated caliper).
✓. Female subjects must be either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence).
✓. General good health confirmed by medical history and skin examination of the treated area.
Exclusion criteria
✕. History of hypertension, ischemic heart disease, valvular heart disease, congestive heart failure, pacemaker/defibrillator, or abdominal aortic aneurism
✕. Not intended to undergo surgery (abdominoplasty)
✕. Current hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue disease
. Having or undergoing any form of treatment for active cancer, or having a history of skin cancer or any other cancer in the areas to be treated, including presence of malignant or pre-malignant pigmented lesions
✕. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator
✕. Having a permanent implant in the treated area, such as metal plates, or an injected chemical substance such as silicone
✕. Having undergone any other surgery in the treatment area within 12 months of treatment or during the study, including liposuction
✕. Previous body contouring procedures in the treatment area within 12 months