Study of Low Level Laser Therapy for Body Contouring
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|ClinicalTrials.gov Identifier: NCT00738426|
Recruitment Status : Completed
First Posted : August 20, 2008
Results First Posted : May 2, 2014
Last Update Posted : February 10, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Body Contouring||Device: Erchonia ML Scanner (MLS) Device: Sham device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||July 2008|
Active Comparator: Erchonia ML Scanner (MLS)
Red diode low level laser light energy
Device: Erchonia ML Scanner (MLS)
Red diode low level laser light energy.
Sham Comparator: Sham device
non-therapeutic sham light output
Device: Sham device
non-therapeutic light energy output
- Incidence of the Reduction of at Least 3.0 Inches Off Their Combined Waist-hips-thighs Circumference. [ Time Frame: 2 weeks ]
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00738426
|United States, Florida|
|Douglas D. Dedo, MD, FACS|
|Palm Beach Gardens, Florida, United States, 33410|
|United States, Indiana|
|Marion, Indiana, United States, 46952|
|United States, Michigan|
|Dr. Gregory C. Roche|
|Bloomfield Hills, Michigan, United States, 48302|
|Principal Investigator:||Gregory C Roche, MD, FACS|
|Principal Investigator:||Robert F Jackson, MD, FACS|
|Responsible Party:||Erchonia Corporation|
|Other Study ID Numbers:||
|First Posted:||August 20, 2008 Key Record Dates|
|Results First Posted:||May 2, 2014|
|Last Update Posted:||February 10, 2020|
|Last Verified:||January 2020|
non-invasive body contouring of waists hips and thighs