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The purpose of this study is to determine whether red light therapy using LED 650nm red light for body contouring of the waist, hips and thighs is as effective as red light therapy using Laser 635nm red light.
Red light laser therapy using 635nm red light laser technology has previously been shown to cause lipolysis in subcutaneous fat as a non-surgical method to promote weight loss and body contouring. This study hypothesizes that red LED light therapy using 650nm red light LED (light emitting diode) technology produces similar results to the laser device (red LASER 635nm) when preformed using a specified treatment protocol.
Furthermore, it is hypothesized that the Vevazz therapy program achieves the results after a single 28 minute treatment. The predicate 635nm LED device (Photonica Professional by Ward Photonics) achieves its results after one 32 minute therapy program.
The Vevazz therapy program uses the Vevazz LED device for fat removal using LED red light therapy. This multi-site study reviews results from 66 randomly selected patients after a single treatment using the Vevazz LED device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Device | Experimental | Active Device: Vevazz LED red light therapy system Vevazz LED red light therapy system is a treatment regimen using the Vevazz LED device for fat removal using LED red light therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vevazz LED | Device | Vevazz LED red light therapy is a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist and thighs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fat Amount (Reduction) in Treatment Area as Measured in Inches Lost | Circumferential measurement of thighs, hips and waist before and after treatment. | One 28 minute treatment session. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jamie Fettig | Owner | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vevazz, LLC | Dallas | Texas | 75204 | United States |
No current plan to share data.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 15, 2017 | |
| Reset | Jan 12, 2018 | |
| Release | Jul 3, 2018 | |
| Reset | Jul 30, 2018 | |
| Release | Aug 7, 2018 | |
| Reset | Sep 6, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 15, 2017 | Jan 12, 2018 | |||
| Jul 3, 2018 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Jul 30, 2018 |
| Aug 7, 2018 | Sep 6, 2018 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |