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| Name | Class |
|---|---|
| Syneron Medical | INDUSTRY |
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The primary objective of this study is to evaluate the effectiveness of the Contour I VER 3.1 System on abdominal midsection circumference reduction relative to no treatment.
The secondary objective of this study is to assess subject satisfaction measured with a self-assessment questionnaire
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Non Invasive Ultrasound | Experimental | Group 1 3 visits - Measurement of abdominal circumferences 3 visits - Treatment with Ultrashape Contour I VER 3.1 4 visits - Follow up visits The intervention is non invasive ultrasound. |
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| Group 2 - Non Invasive Ultrasound | Experimental | Group 2 3 visits - Treatment with Contour I VER 3.1 system 3 visits - Measurements of abdominal circumference 4 visits - Follow Up visits The intervention is non invasive ultrasound. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non Invasive Ultrasound | Device | Each treatment session is estimated to take approximately 60 minutes and will be performed on a bi-weekly basis. |
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| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of this study is to evaluate the effectiveness of the Contour I VER 3.1 System on abdominal midsection circumference reduction relative to no treatment | Reduction in circumference measurement of the abdomen from baseline | 5-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assess subject satisfaction measured with a self-assessment questionnaire | 5-6 months |
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Inclusion Criteria:
Female or male subjects, 18 and 65 years of age at the time of enrollment
Abdominal fat thickness of at least 1.5 cm (measurement by caliper)
For women of child-bearing potential:
General good health confirmed by medical history and skin examination of the treated area
Written informed consent to participate in the study
Ability to comply with the requirements of the study
BMI ≤ 30
Intra-procedural Inclusion criteria (prior to starting the treatment phase):
subjects are eligible to continue the study and participate in the treatment phase if she meets all of the following intra-procedural inclusion criteria:
For women of child-bearing potential: negative pregnancy test
Abdominal fat thickness of at least 1.5 cm prior to initial treatment (measurement by caliper)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. William Patrick Coleman, III | Metairie | Louisiana | 70006 | United States | ||
| MD Laser Skin & Vein Institute |
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| Hunt Valley |
| Maryland |
| 21030 |
| United States |
| New-Jersey Plastic Surgery | Montclair | New Jersey | 07042 | United States |
| Dr. Jeffrey Kenkel | Dallas | Texas | 75390-9132 | United States |
| Department of Plastic Surgery and Burns Rabin Medical Center - Beilinson Hospital | Petah Tikva | 49100 | Israel |