Unwanted Fat
Conditions
Brief summary
Prospective, one arm, baseline-controlled clinical study for the evaluation of UltraShape contour I V3 for non-invasive fat reduction. The study will conduct using the UltraShape contour I V3 using U-Sculpt/VDF transducer on the abdomen.
Detailed description
This study is a prospective, one arm, up to four sites, clinical study showing the performance and safety of the UltraShape contour I V3 device non-invasive abdominal fat reduction for subjects with body mass index (BMI) above 28. Up to 60 healthy subjects will be enrolled. All subjects will undergo an assessment of their general health. During the treatment period, subject's fat thickness and circumferences will be measured and three successive UltraShape contour I V3 treatments will be performed (two weeks interval). Subjects will undergo treatment with the UltraShape contour I V3 using the U-Sculpt/VDF transducer on the abdomen area. Follow-up (FU) visits will be conducted as follows: 4 weeks FU, 8 weeks FU and 12 weeks FU post last treatment (Tx.3). Subject's fat thickness and circumference will be measured at each visit. Subject's blood test will be taken at baseline (prior to the first treatment, pre Tx.1), before the third treatment (pre Tx.3) and at 12 weeks follow-up visit (12wk FU). No Pregnancy will be verified before first treatment as well. In all following visits (TX2, Tx3 and FU 1 FU 2 and FU3), lack of pregnancy will be verified by questioning. Additionally, subject satisfaction and investigator satisfaction questionnaires will be completed at each FU visit. Finally, photography will be performed under visible light conditions of the front, right and left view. Optional, 3D photographs will be taken at each visit (at treatment visits, prior to treatments).
Interventions
DEVICEUltraShape Contour I V3
Tissue selectivity is achieved by a proprietary knowledge of parameters ensuring specific destruction of the fat cells only within the target area. All other types of tissue, such as blood vessels, muscles and peripheral nerves remain intact. There are no thermal effects. Fat cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time
Sponsors
Syneron Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
subject is eligible to participate in the study if he or she meets all the following inclusion criteria: 1. Signed informed consent to participate in the study. 2. Female and male subjects,18 and 60 years of age at the time of enrolment 3. Fitzpatrick Skin Type I to VI. 4. Abdominal fat thickness of at least 1.5 cm (measured by calibrated caliper). 5. BMI above 28 (normal to overweight). 6. If female, not pregnant, lactating and 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). 7. Negative urine pregnancy test as tested before the first treatment for women with bearing potential (e.g. not menopause). In addition, negative pregnancy following pregnancy inquiry for each visit (treatments and follow up), starting from the second treatment. 8. General good health confirmed by medical history and skin examination of the treated area. 9. Willing to follow the treatment and follow-up schedule and post-treatment care instructions. 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
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 |
|---|---|---|
| Change in abdominal fat thickness compared to baseline | Baseline and 12 weeks | Abdominal fat thickness reduction post UltraShape contour I V3 treatments at 12 weeks follow-up (12wk FU) versus baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in abdominal fat thickness compared to baseline | Baseline, 8 weeks and 16 weeks | Abdominal fat thickness reduction as measured by Ultrasound device post UltraShape contour I V3 treatments at follow-up visits |
| Change in abdominal circumference reduction compared to baseline | Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeks | Abdominal circumference reduction post UltraShape contour I V3 treatments at all treatment visits and follow-up visits |
| Blood panel and fat lipid profile compared to baseline levels | Baseline, 4 weeks and 16 weeks | Blood elements levels (e.g. lipids, Glucose) before the third treatment (at 4 weeks) and at the last follow-up visit (at 16 weeks) versus baseline |
| Subject satisfaction | 8 weeks, 12 weeks, and 16 weeks | Subject satisfaction: success is defined as when at least 50% of the subjects are satisfied with treatment results at each of the follow up visits |
| Comfort level during treatment | day 0, 2 weeks, and 4 weeks | Comfort assessment will be performed independently by subjects using a numerical scale. Subjects will assess treatment comfort immediately post each of the three treatments |
| Investigator satisfaction | 8 weeks, 12 weeks, and 16 weeks | Investigator satisfaction: success is defined as when at least 50% of the observations are ranked as at least satisfied by the study investigator at each of the follow up visits |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events | day 0 until 16 weeks | Description, severity, intervention and outcome of adverse events will be reported on an adverse event form and number of participants will be reported |
Countries
United States
Outcome results
None listed