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The purpose of this study is to determine if 532nm green diode laser light is effective in body contouring of the waist, hips and thighs.
Weight loss and body contouring are large, constantly-growing fields of cosmetic surgery. However, while the demand for body shaping procedures is constantly on the rise, so is the demand for such procedures to be performed more quickly, simply and most importantly, less invasively; hence the growing popularity of non- to minimally-invasive cosmetic surgery procedures. In 2005, more than 7.5 million minimally-invasive cosmetic procedures were performed, a 35% increase from 2000.
In recent years, Erchonia Corporation, a manufacturer of low level lasers, has developed a dual-diode laser that emits 532 nm and 635nm collimated line-generated beams to emulsify fat. In August, 2010, the Erchonia® ML Scanner (MLS) 635nm was cleared by FDA for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. It was determined that the biochemical effect of the Erchonia® MLS stimulates the mitochondria of the adipocyte cells which in turn increases the production of ATP. The newly synthesized ATP triggers the up-regulation of cyclic adenosine monophosphate (cAMP). cAMP has been shown to stimulate cytoplasmic lipase, triggering the conversion of triglycerides into fatty acids and glycerol that can easily pass through the cell membrane. The transitory pore is evidence that the laser is allowing for the movement of fatty acids, glycerol, and triglycerides to pass across the membrane and into extra-cellular space. Through vasodilation of nearby blood vessels and arteries, oxidization of the triglycerides and fatty acids occurs within the extra-cellular space.
This pilot study will apply the Erchonia® MLS employing 532 nm green diodes in lieu of 635 nm red diodes to compare the results to those attained using the 635 nm diodes. The Sponsor believes the use of 532 nm diodes may prove as effective as 635 nm diodes combined with a reduction in total procedure administration time from 40 to 30 minutes. It is the goal of this study to evaluate this hypothesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erchonia GLS 532nm | Experimental | 532nm green laser light therapy. |
|
| Placebo laser | Sham Comparator | Sham light output with no therapeutic benefit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erchonia GLS | Device | 532 nm green diode low level laser light device |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Combined Circumference in Inches of the Waist, Hips and Bilateral Thighs | Mean change in total combined circumference inches of the waist, hips and bilateral thighs from baseline to endpoint evaluation. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory C Roche, MD, FACS | Principal Investigator | |
| Robert F Jackson, MD, FACS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Surgeon's Inc. | Marion | Indiana | 46952 | United States | ||
| Bloomfield Laser and Cosmetic Surgery Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Erchonia GLS 532nm | 532nm green laser light therapy. Erchonia GLS: 532 nm green diode low level laser light device |
| FG001 | Placebo Laser | Sham light output with no therapeutic benefit Placebo laser: Sham light output with no therapeutic benefit |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Erchonia GLS 532nm | 532nm green laser light therapy. Erchonia GLS: 532 nm green diode low level laser light device |
| BG001 | Placebo Laser | Sham light output with no therapeutic benefit Placebo laser: Sham light output with no therapeutic benefit |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Combined Circumference in Inches of the Waist, Hips and Bilateral Thighs | Mean change in total combined circumference inches of the waist, hips and bilateral thighs from baseline to endpoint evaluation. | Posted | Mean | Standard Deviation | inches | 2 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Erchonia GLS 532nm | 532nm green laser light therapy. Erchonia GLS: 532 nm green diode low level laser light device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elvira Walls | Regulatory Insight, Inc. | 615-712-9743 | elvira@reginsight.com |
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| Placebo laser |
| Device |
Sham light output with no therapeutic benefit |
|
| Bloomfield Hills |
| Michigan |
| 48302 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Placebo Laser | Sham light output with no therapeutic benefit Placebo laser: Sham light output with no therapeutic benefit | 0 | 32 | 0 | 32 |
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