Unwanted Abdomen Fat
Conditions
Keywords
abdominoplasty
Brief 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
Detailed description
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.
Interventions
DEVICEVelaShape device
Modified VelaShape radiofrequency device for non invasive fat reduction treatment.
DEVICEContour I V3 device
Contour I V3 device are non invasive for fat reduction.
Sponsors
Syneron Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Signed informed consent to participate in the study. 2. Scheduled date for surgery (abdominoplasty). 3. Agree to provide samples for histology from the abdominoplasty. 4. Female and male subjects, between 18 to 60 years of age at the time of enrollment 5. Fitzpatrick Skin Type I to VI. 6. For Contour I V3 treatment only: Abdominal fat thickness of at least 1.5 cm (measured by calibrated caliper). 7. 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). 8. General good health confirmed by medical history and skin examination of the treated area. 9. Willing to follow the treatment and to provide histology samples during the surgery from the intended to be harvested areas. 10. Willingness to refrain from a change in diet/ exercise/medication regimen for the entire course of the study. 11. Willing to have photographs and images taken of the treated areas to be used (with de-identification) in evaluations, publications and presentations
Exclusion criteria
A subject is not eligible for participation in this study if he/she meets any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| histology following VelaShape treatment | day 10 up to 90 days | Evaluate abdominal fat reduction post VelaShape treatment vs.control |
| Histology following Contour I V3 treatment | day 10 up to 90 days | Evaluate Abdominal fat reduction post Contour I V3 treatment vs. control |
Countries
Israel
Contacts
Primary ContactDr. Dean Ad-El, M.D
Outcome results
None listed