Status:
COMPLETED
Study of Low Level Laser Therapy to Reduce Body Circumference in Obese Individuals
Lead Sponsor:
Erchonia Corporation
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether low level laser light therapy is effective in reducing circumference of the waist, hips and upper abdomen in obese individuals.
Detailed Description
The American Society of Plastic Surgeons (ASPS) 2011 report states that the market for cosmetic procedures has shown significant growth over the past two years, with 13.8 million cosmetic plastic surg...
Eligibility Criteria
Inclusion
- Body Mass Index (BMI) is between 30 kg/m² and 40 kg/m², inclusive.
- Subject indicated for liposuction or use of liposuction techniques for the removal of localized deposits of adipose tissues that do not respond to diet and exercise; specifically for the indication of body contouring in the areas of the hips, waist and upper abdomen. (As per the American Academy of Cosmetic Surgery's 2006 Guidelines for Liposuction Surgery developed by A joint Ad Hoc Committee of the American Society of Lipo-Suction Surgery (ASLSS) and the American Academy of Cosmetic Surgery (AACS))
- Subject is willing and able to abstain from partaking in any treatment other than the study procedure (existing or new) to promote body contouring/ circumference reduction/weight loss during the course of study participation.
- Subject is willing and able to maintain his or her regular (typical pre-study) diet and exercise regimen without effecting significant change in either direction during study participation
Exclusion
- Body Mass Index (BMI) is less than 30 kg/m² or greater than 40 kg/m².
- Known cardiovascular disease such as cardiac arrhythmias, congestive heart failure.
- Cardiac surgeries such as cardiac bypass, heart transplant surgery, pacemakers.
- Prior surgical intervention for body sculpting/weight loss, such as liposuction, abdominoplasty, stomach stapling, lap band surgery, etc.
- Medical, physical, or other contraindications for body sculpting/weight loss.
- Current use of medication(s) known to affect weight levels/cause bloating or swelling and for which abstinence during the course of study participation is not safe or medically prudent.
- Any 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.
- Known photosensitivity disorder.
- Current active cancer or currently receiving treatment for cancer.
- Pregnant or planning pregnancy prior to the end of study participation.
- Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in past two years.
- Developmental disability or cognitive impairment that in the opinion of the investigator 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 a clinical study or other type of research in the past 30 days
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT01821352
Start Date
March 1 2013
End Date
April 1 2014
Last Update
December 11 2015
Active Locations (2)
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1
Surgeons Inc.
Noblesville, Indiana, United States, 46060
2
Bloomfield Laser and Cosmetic Surgery Center
Bloomfield Hills, Michigan, United States, 48302