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The purpose of this study is to compare the clinical performance of the Ultrashape system with VelaShape II device for reduction of the waist.
UltraShape® Contour I V3 system is a non-invasive (not breaking the skin) focused ultrasound for body contouring purposesdesigned to selectively disrupt sub-dermal fat cells employing focused ultrasound. 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.
VelaShape is a non-invasive device for Body Reshaping and Cellulite Treatment. VelaShape combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with mechanical manipulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Velashape II device | Active Comparator | Controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with mechanical manipulation. |
|
| Ultrashape | Active Comparator | The UltraShape Contour I V3 uses focused ultrasound to produce localized mechanical motion within fat tissues and cells for the purpose of producing mechanical cellular membrane disruption. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrashape | Device | All subjects receive 3 successive Ultrashape treatments every two weeks in the anterior abdomen. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in circumference reduction between baseline and follow-up visits | The primary efficacy endpoint in this trial is the statistical difference in circumference reduction between Control (baseline measurement, Vist 2 / Day 0) and two points of follow-up measurement: 2 weeks (Visit 5 / Day 42) and 12 weeks (Visit 8 / Day 112) following the last Tx session. The following procedure will be used to compute the Circumference Difference primary endpoint: | Base line, 2 and 12 weeks post last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Safety will be evaluated based on the incidence and severity of adverse events caused by the treatments | The duration of the study, an expected average of 5 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Satisfaction Scores | Subject Satisfaction Scores using the Global Aesthetic Improvement (GAI) Scale at each treatment and follow-up time point post treatment: 2 week, 4 week, 6 week, 8 week, 10 week and 12 week in a study. | 2, 4, 6, 8,10 and 12 week in a study. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shlomit Mann | Syneron Medical Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Laser & SkinCare Clinic | Surrey | British Columbia | V3T 1W7 | Canada | ||
| Cosmedica |
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| Velashape II | Device | All subjects receive 3 successive Velashape treatments every two weeks in the anterior abdomen. |
|
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| Pointe-Claire |
| Quebec |
| H9R 5N3 |
| Canada |