Study to See How Low Level Laser Light Affects Subcutaneous Fat Around the Hips and Waist

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Weight Loss

In brief

The purpose of this pilot study is to demonstrate the anatomical modulation of subcutaneous fat across the waist and hips that occurs through application of the Erchonia® ML Scanner (MLS) Laser manufactured for non-invasive body contouring of the waist and hips.

Key facts

Study ID

NCT01292564

Run by

Erchonia Corporation

People needed

0

Starts

2011-02-01

Expected to finish

2012-08-01

Last updated by the study team

2014-05-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subject indicated for liposuction or use of liposuction techniques for the removal of localized deposits of adipose tissues; specifically for the indication of body contouring in the areas of the waist and hips. (As per the American Academy of Cosmetic Surgery's 2006 Guidelines for Liposuction Surgery).
• Body Mass Index (BMI) of 28 to 43 kg/m², inclusive.
• It is deemed safe for the subject to undergo a MRI procedure based on the MRI screening questionnaire.
• Subject is willing and able to abstain from partaking in any treatment other than the study procedure to promote body contouring and/or weight loss during study participation.
• Subject is willing and able to maintain his or her regular diet and exercise regimen without effecting significant change in either direction during study participation.

You may not qualify if…

• Body Mass Index (BMI) is less than 28 kg/m² or greater than 43 kg/m².
• Diabetes dependent on insulin or oral hypoglycemic medications.
• Known cardiovascular disease.
• Prior cardiac surgery.
• 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/bloating/swelling and for which abstinence during study participation is not safe or medically prudent.
• Any medical condition known to affect weight levels/cause bloating/swelling.
• Diagnosis of, and/or taking medication for, irritable bowel syndrome.
• Active infection, wound or other external trauma to the laser treatment area.
• Pregnant, breast feeding, or planning pregnancy prior to study end.
• Serious mental health illness such as dementia or schizophrenia; 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 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 30 days.

Where it is running

• American Laser Centers — Fox River Grove, Illinois, United States

Full record on ClinicalTrials.gov

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