Study of Low Level Laser Therapy for Body Contouring

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Erchonia Corporation
ClinicalTrials.gov Identifier:
NCT00738426
First received: August 18, 2008
Last updated: April 1, 2014
Last verified: April 2014

August 18, 2008
April 1, 2014
October 2007
June 2008   (final data collection date for primary outcome measure)
Incidence of the Reduction of at Least 3.0 Inches Off Their Combined Waist-hips-thighs Circumference. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00738426 on ClinicalTrials.gov Archive Site
Changes in Weight, Body Mass Index (BMI) and Scores on the Body Shape Questionnaire (BSQ). [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Low Level Laser Therapy for Body Contouring
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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Body Contouring
  • Device: Erchonia ML Scanner (MLS)
    Red diode low level laser light energy.
  • Device: Sham device
    non-therapeutic light energy output
  • Active Comparator: Erchonia ML Scanner (MLS)
    Red diode low level laser light energy
    Intervention: Device: Erchonia ML Scanner (MLS)
  • Sham Comparator: Sham device
    non-therapeutic sham light output
    Intervention: Device: Sham device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
July 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • indicated for liposuction for the removal of localized deposits of adipose tissues that do not respond to diet and exercise; specifically in the areas of the waist, hips and bilateral thighs.
  • willing and able to abstain from partaking in any treatment other than the study procedure (existing or new) to promote body contouring and/or weight loss during the course of study participation.
  • willing and able to maintain regular diet and exercise regimen without during study participation.
  • 18 to 65 years.
  • Male or female.

Exclusion Criteria:

  • Body Mass Index (BMI) of 30 kg/m² or greater.
  • Diabetes dependent on insulin or oral hypoglycemic medications.
  • known cardiovascular disease.
  • cardiac surgeries, pacemakers.
  • excessive alcohol consumption.
  • prior surgical intervention for body sculpting/weight loss.
  • medical, physical, or other contraindications for body sculpting/weight loss.
  • current use of medication(s) known to affect weight levels and/or to cause bloating or swelling and for which abstinence during the course of study participation is not safe or medically prudent.
  • medical condition known to affect weight levels and/or to cause bloating or swelling.
  • diagnosis of, and/or taking medication for, irritable bowel syndrome.
  • active infection, wound or other external trauma to the areas to be treated with the laser.
  • pregnant, breast feeding, or planning pregnancy prior to study end.
  • serious mental health illness; psychiatric hospitalization in past two years.
  • developmental disability or cognitive impairment that would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements.
  • involvement in litigation and/or a worker's compensation claim and/or receiving disability benefits related to weight-related and/or body shape issues.
  • participation in research in the past 90 days.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00738426
BCL-001
No
Erchonia Corporation
Erchonia Corporation
Not Provided
Principal Investigator: Gregory C Roche, MD, FACS
Principal Investigator: Robert F Jackson, MD, FACS
Erchonia Corporation
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP