VelaShape III & UltraShape Power for Thigh Circumference Reduction
Prospective, one-arm, baseline-controlled pilot study for the evaluation of the VelaShape III combined with UltraShape Power treatment for non-invasive circumference reduction to the thighs.
Study Start Date
January, 15 2018
Estimated Completion Date
- Device: UltraShape Power
- Device: VelaShape III
Syneron Medical -- DHF24451
1. Signed informed consent to participate in the study.
2. Female and male subjects, 18 and 60 years of age at the time of enrollment.
3. Fitzpatrick Skin Type I to VI.
4. Fat thickness of at least 1.5 cm (measured by calibrated caliper).
5. BMI interval: 22 ? BMI ? 30 (normal to overweight, but not obese).
6. 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
7. In addition, negative urine pregnancy test as tested before each treatment and at the
last visit for women with child-bearing potential (e.g. not menopausal).
8. General good health confirmed by medical history and skin examination of the treated
9. Willing to follow the treatment and follow-up schedule and post-treatment care
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
de-identified in evaluations, publications and presentations.
1. History of hypertension, ischemic heart disease, valvular heart disease, congestive
heart failure, pacemaker/defibrillator, abdominal aortic aneurism.
2. Known hyperlipidemia, diabetes mellitus, hepatitis, liver disease, HIV positive
status, blood coagulopathy or excessive bleeding, autoimmune or connective tissue
3. 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.
4. Having any active electrical implant anywhere in the body, such as a pacemaker or an
5. Having a permanent implant in the treated area, such as metal plates or an injected
chemical substance such as silicone.
6. Having undergone any other surgery in the treated areas within 12 months of treatment
or during the study, including liposuction.
7. Previous body contouring procedures in the treatment area within 12 months.
8. History of skin disease in the treatment area, known tendency to form keloids or poor
9. Known photosensitivity.
10. Suffering from significant skin conditions in the treated areas or inflammatory skin
conditions, including, but not limited to, open lacerations or abrasions and active
cold sores or herpes sores prior to treatment (duration of resolution as per the
Investigator's discretion) or during the treatment course.
11. Skin lesions in the treatment area other than simple nevi on physical examination
(e.g., atypical nevus, tattoo, abrasions) including depressed scars in the treatment
12. Very poor skin quality (i.e., severe laxity).
13. Abdominal wall diastasis or hernia on physical examination.
14. Abnormal kidney, liver or coagulation functions, abnormal lipid profile or blood count
within the last 3 months.
15. Obesity (BMI > 30).
16. Pregnant, childbirth within the last 12 months or breastfeeding women.
17. Any acute or chronic condition which, in the opinion of the investigator, could
interfere with the conduct of the study.
18. Unstable weight within the last 6 months (i.e., ± 3% weight change in the prior six
19. Inability to comply with circumference measurement procedure (e.g., inability to hold
breath for the required duration).
20. Abdominal fat thickness lower than 2.5 cm after strapping.
21. Participation in another clinical study within the last 6 months.
22. As per the Investigator's discretion, any physical or mental condition which might
make it unsafe for the subject to participate in this study.
18 Years to 60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Study Locations and Contact Information (1)
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