Status:
COMPLETED
Study of Low Level Laser Therapy for Body Contouring
Lead Sponsor:
Erchonia Corporation
Conditions:
Body Contouring
Eligibility:
All Genders
18-65 years
Phase:
NA
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 procedu...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00738426
Start Date
October 1 2007
End Date
July 1 2008
Last Update
February 10 2020
Active Locations (3)
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1
Douglas D. Dedo, MD, FACS
Palm Beach Gardens, Florida, United States, 33410
2
Cosmetic Surgery
Marion, Indiana, United States, 46952
3
Dr. Gregory C. Roche
Bloomfield Hills, Michigan, United States, 48302