Excess Abdominal Fat
Conditions
Brief summary
Prospective, blinded, one arm, baseline-controlled clinical study for the evaluation of the UltraShape treatment for non-invasive abdominal fat reduction. Study subjects will undergo UltraShape treatments on the abdominal area
Detailed description
This study is a prospective, baseline and blinded controlled, one arm clinical study showing the performance and safety of the UltraShape treatment for non-invasive abdominal fat reduction. Up to 60 Healthy subjects in up to 4 investigational sites will be enrolled in this study. All subjects will undergo an assessment of their general health. During the treatment period, subject's fat thickness and circumference will be measured and three successive UltraShape treatments, two weeks interval, will be performed. The study subjects will undergo UltraShape treatments on the abdomen. During the follow-up period visit will be conducted as follow: 4 weeks (4wk FU), 8 weeks (8wk FU) and 12 weeks (12wk FU) post last treatment (Tx.3). Subject's abdominal fat thickness and circumference will be measured in the measurements points and will be assessed at each visit. Additionally, a subject questionnaire will be completed in each follow-up visit (4wk, 8wk and 12wk FU). Finally, photography will be performed under visible light conditions of the front, right, left and back view. Most of the assessments will occur at each of the visits (all treatments and all follow-up visits) to the clinic.
Interventions
DEVICEUltraShape
Tissue selectivity is achieved by a proprietary knowledge of ultrasound 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
A subject is eligible to participate in the study if he/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 enrollment 3. Fitzpatrick Skin Type I to VI. 4. Fat thickness of at least 1.5 cm in the treated area (measured by calibrated caliper). 5. BMI interval: BMI between 22 to 30 (normal to overweight, but not obese). 6. If female, not pregnant or lactating, 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. In addition, negative urine pregnancy test as tested before each treatment and at the last follow-up visit for women with child-bearing potential (e.g. not menopause). 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 or she meets any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abdominal fat thickness Reduction | 16 weeks | Abdominal fat thickness Reduction post UltraShape treatments at 12 weeks follow-up (12wk FU) versus baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abdominal fat thickness reduction as measured by Ultrasound | 8wk , 12wk , and 16wk | Abdominal fat thickness reduction as measured by Ultrasound device post UltraShape treatments at all follow-up visits (4wk FU, 8wk FU, and 12wk FU) versus baseline |
| Abdominal fat thickness reduction as measured by caliper | 8wk , 12wk , and 16wk | Abdominal fat thickness reduction as measured by caliper post UltraShape treatments at all follow-up visits (4wk FU, 8wk FU, and 12wk FU) versus baseline |
| Abdominal circumference reduction | 2 weeks , 4 weeks, 8wk , 12wk , and 16wk | Abdominal circumference reduction post UltraShape treatments at all visits (treatments (pre Tx. 2; pre Tx.3) and follow up (4wk FU, 8wk FU, and 12wk FU)) versus baseline |
| Evaluate the safety of the treatment | day 0 until 16 weeks | Evaluate the safety of the treatment with the UltraShape device on abdominal area |
| Subject satisfaction: | 8wk , 12wk , and 16wk | Satisfaction assessment will be performed independently by the subject himself using 5 points Likert scale questionnaire at all follow-up visits (4wk FU, 8wk FU, and 12wk FU). |
| Comfort level during treatment: | day 0 , 2 weeks , 4 weeks | Comfort assessment will be performed independently by the subject himself using a numerical scale. The subjects will answer this questionnaire after each of the three treatments |
| Investigator satisfaction: | 8wk , 12wk , and 16wk | Satisfaction assessment will be performed independently by the investigator himself using 5 points Likert scale questionnaire at all follow-up visits (4wk FU, 8wk FU and 12wk FU) |
Countries
United States
Contacts
Primary ContactJeffrey S Dover, M.D
Outcome results
None listed