Study of Low Level Laser Therapy to Reduce Body Circumference in Obese Individuals (NCT01821352) | Clinical Trial Compass
CompletedNot Applicable
Study of Low Level Laser Therapy to Reduce Body Circumference in Obese Individuals
United States53 participantsStarted 2013-03
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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.
*…
What they're measuring
1
Difference in the Proportion of Primary Outcome Successes Between Treatment Groups for Change in Combined Circumference Measurements