Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether green diode low level laser therapy is effective for body contouring of the waist, hips and thighs.
Weight loss and body contouring are large, constantly-growing fields of cosmetic surgery. According to the American Society of Plastic Surgeons (ASPS) statistics, more than 324,000 liposuction procedures, 233,000 eyelid surgeries and 114,000 facelift procedures were performed in 2004 in the United States alone. 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. Cosmetic surgery patients are no longer satisfied with procedures that require general anesthesia, pose a multitude of potentially serious risks and complications and that require several weeks of recovery time. 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. Consequently, patients and physicians alike are continually searching for non-invasive alternatives to traditional cosmetic procedures such as liposuction that are efficient, safe and effective.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erchonia ML Scanner (MLS) | Active Comparator | Red diode low level laser light energy |
|
| Sham device | Sham Comparator | non-therapeutic sham light output |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erchonia ML Scanner (MLS) | Device | Red diode low level laser light energy. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of the Reduction of at Least 3.0 Inches Off Their Combined Waist-hips-thighs Circumference. | 2 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gregory C Roche, MD, FACS | Principal Investigator | |
| Robert F Jackson, MD, FACS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Douglas D. Dedo, MD, FACS | Palm Beach Gardens | Florida | 33410 | United States | ||
| Cosmetic Surgery |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Erchonia ML Scanner (MLS) | red diode low level laser light energy Erchonia ML Scanner (MLS): Red diode low level laser light energy. |
| FG001 | Sham Device | non-therapeutic sham light output Sham device: non-therapeutic light energy output |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Erchonia ML Scanner (MLS) | Red diode low level laser light energy Erchonia ML Scanner (MLS): Red diode low level laser light energy. |
| BG001 | Sham Device | non-therapeutic sham light output Sham device: non-therapeutic light energy output |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Sex: Female, Male | Count of Participants |
| 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 | Incidence of the Reduction of at Least 3.0 Inches Off Their Combined Waist-hips-thighs Circumference. | Posted | Number | participants | 2 weeks |
|
|
2 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Erchonia ML Scanner (MLS) | red diode low level laser light energy Erchonia ML Scanner (MLS): Red diode low level laser light energy. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert F. Jackson | Cosmetic Surgery | 765-662-8303 | rjlipodr@comteck.com |
Not provided
Not provided
Not provided
Not provided
Not provided
| Sham device |
| Device |
non-therapeutic light energy output |
|
| Marion |
| Indiana |
| 46952 |
| United States |
| Dr. Gregory C. Roche | Bloomfield Hills | Michigan | 48302 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Age, Categorical | Count of Participants | Participants |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Sham Device | non-therapeutic sham light output Sham device: non-therapeutic light energy output | 0 | 32 | 0 | 32 |
Not provided
Not provided