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Study of Low Level Laser Therapy for Body Contouring

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00738426
Recruitment Status : Completed
First Posted : August 20, 2008
Results First Posted : May 2, 2014
Last Update Posted : May 2, 2014
Sponsor:
Information provided by (Responsible Party):
Erchonia Corporation

Tracking Information
First Submitted Date  ICMJE August 18, 2008
First Posted Date  ICMJE August 20, 2008
Results First Submitted Date  ICMJE February 25, 2014
Results First Posted Date  ICMJE May 2, 2014
Last Update Posted Date May 2, 2014
Study Start Date  ICMJE October 2007
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2008)
Incidence of the Reduction of at Least 3.0 Inches Off Their Combined Waist-hips-thighs Circumference. [ Time Frame: 2 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00738426 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2008)
Changes in Weight, Body Mass Index (BMI) and Scores on the Body Shape Questionnaire (BSQ). [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Low Level Laser Therapy for Body Contouring
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Body Contouring
Intervention  ICMJE
  • Device: Erchonia ML Scanner (MLS)
    Red diode low level laser light energy.
  • Device: Sham device
    non-therapeutic light energy output
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 19, 2008)
72
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00738426
Other Study ID Numbers  ICMJE BCL-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Erchonia Corporation
Study Sponsor  ICMJE Erchonia Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gregory C Roche, MD, FACS
Principal Investigator: Robert F Jackson, MD, FACS
PRS Account Erchonia Corporation
Verification Date April 2014

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