N/A
N=67
Study of the Effectiveness of Green Diode Laser Light on Body Shaping
Body Contouring
Bottom Line
View on ClinicalTrials.gov: NCT01292538 ↗Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Jun 2014
Primary outcome: Primary: Combined Circumference in Inches of the Waist, Hips and Bilateral Thighs — -3.895; -1.136 inches
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Erchonia GLS (Device); Placebo laser (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Erchonia Corporation
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Combined Circumference in Inches of the Waist, Hips and Bilateral Thighs |
-3.895; -1.136 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01292538). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.