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The aim of the study is to evaluate the safety, efficacy, patient comfort and patient satisfaction after Evoke treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments (Tx.1, Tx.2 and Tx.3). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evoke Device | Device | Subjects will undergo treatment with Evoke Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Change in Skin Appearance | Picture evaluation by blinded investigators. | 1 month, 3 month, 6 months |
| Evaluate rate of Change in Skin Appearance using 3D Photographic analysis | 3D Photographic analysis will be conducted using QuantifiCare System | 1 month, 3 month, 6 months |
| Evaluate changes in skin using VivoSight Optical Coherence Tomography (OCT) software | Non-invasive in vivo skin imaging will be taken with the VivoSight Optical Coherence Tomography (OCT). | 1 month, 3 month, 6 months |
| Evaluate changes in skin appearance comparing photographs using Mechanical Turk (MTurk). The pictures will be sent through the system and evaluated by crowd workers. | The pictures will be sent through the system and evaluated by crowd workers. | 1 month, 3 month, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Investigator assessment of the skin appearance improvement | Investigator assessment of the skin appearance improvement comparing pre and post treatment using 0 - 4 -points Likert scale at 1 month, 3 months and 6 months follow up visits: • 4 = Significantly marked improvement; 3 = Marked improvement; 2 = Moderate improvement; 1 = Slight improvement; 0 = No difference | 1 Month, 3 Months, 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erez Dayan, MD | Avance Plastic Surgery Institute 5570 Longley Lane, Suite A Reno, NV 89511 | Principal Investigator |
| Christopher Chia, MD | BodySculpt 128 Central Park S New York, NY 10019 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Avance Plastic Surgery Institute | Reno | Nevada | 89511 | United States | ||
| Union Square Laser Dermatology |
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| Evaluate Subject assessment of improvement and satisfaction | Improvement assessment will be performed independently by the subject himself 4 points Likert scale questionnaire (Global Aesthetic Improvement Scale), as follows: • 4 = Significantly marked improvement; 3 = Marked improvement; 2 = Moderate improvement; 1 = Slight improvement; 0 = No difference. Subject assessment of satisfaction will be filled out by subjects using a 5-points Likert scale, as follows: • +2 = Very satisfied; +1 = Satisfied; 0 = Indifferent; -1 = Disappointed; -2 = Very disappointed. | 1 Month, 3 Months, 6 Months |
| Evaluate histological changes to treatment area skin | Positive changes in histologic evaluation: up to 5 subjects will undergo biopsies of the treated area for histology at baseline and at 3M follow-up visit. Histological sections will be stained using elastin, H&E and other collagen specific stains. | 3 Months |
| New York |
| New York |
| 10003 |
| United States |
| BodySculpt | New York | New York | 10019 | United States |