Study of the Effectiveness of Green Diode Laser Light on Body Shaping

Completed · Not applicable · Has a placebo group

Conditions studied: Body Contouring

In brief

The purpose of this study is to determine if 532nm green diode laser light is effective in body contouring of the waist, hips and thighs.

Key facts

Study ID

NCT01292538

Run by

Erchonia Corporation

People needed

67

Starts

2011-02-01

Expected to finish

2012-06-01

Last updated by the study team

2020-02-10

Who can join

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

You may qualify if…

• Body Mass Index (BMI) less than 30 kg/m²
• 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 waist, hips and bilateral thighs. (As per the American Academy of Cosmetic Surgery's 2006 Guidelines for Liposuction Surgery).
• 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) of 30 kg/m² or greater.
• Diabetic dependent on insulin or oral hypoglycemic medications.
• Known cardiovascular disease.
• Prior cardiac surgery.
• Prior surgical intervention for body sculpting/weight loss, such as liposuction, abdominoplasty, stomach stapling, lap band surgery.
• Medical, physical, or other contraindications for body sculpting/weight loss.
• Use of medication(s) known to affect weight levels and/or to cause bloating or swelling and for which abstinence during study participation is not safe or medically prudent.
• Any medical condition known to affect weight levels and/or 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.
• Photosensitivity disorder.
• Current cancer or receiving treatment for cancer.
• 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/body shape issues.
• Participation in research in the past 30 days.

Where it is running

• Surgeon's Inc. — Marion, Indiana, United States
• Bloomfield Laser and Cosmetic Surgery Center — Bloomfield Hills, Michigan, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.