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Sponsored by: |
Erchonia Medical, Inc. |
Information provided by: | Erchonia Medical, Inc. |
ClinicalTrials.gov Identifier: | NCT00738426 |
The purpose of this study is to determine whether low level laser therapy is effective for body contouring of the waist, hips and thighs.
Condition | Intervention |
Body Contouring |
Device: Erchonia ML Scanner (MLS) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of the Erchonia ML Scanner (MLS)on Body Contouring of the Waist, Hips and Thighs Clinical Study Protocol |
Enrollment: | 72 |
Study Start Date: | October 2007 |
Study Completion Date: | July 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Active Comparator |
Device: Erchonia ML Scanner (MLS)
low level laser therapy
Device: Erchonia ML Scanner (MLS)
low level laser therapy
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B: Sham Comparator |
Device: Erchonia ML Scanner (MLS)
low level laser therapy
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |||||
Douglas D. Dedo, MD, FACS | |||||
Palm Beach Gardens, Florida, United States, 33410 | |||||
United States, Indiana | |||||
Cosmetic Surgery | |||||
Marion, Indiana, United States, 46952 | |||||
United States, Michigan | |||||
Dr. Gregory C. Roche | |||||
Bloomfield Hills, Michigan, United States, 48302 |
Erchonia Medical, Inc. |
Principal Investigator: | Gregory C Roche, MD, FACS | unaffiliated |
Principal Investigator: | Robert F Jackson, MD, FACS | unaffiliated |
Principal Investigator: | Douglas D Dedo, MD, FACS | unaffiliated |
Responsible Party: | Erchonia Medical, Inc. ( Steven Shanks/President ) |
Study ID Numbers: | BCL-001 |
First Received: | August 18, 2008 |
Last Updated: | August 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00738426 |
Health Authority: | United States: Institutional Review Board |
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