Study of Low Level Laser Therapy to Reduce Body Circumference in Obese Individuals
A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of the Erchonia Obesity Laser on the Reduction of Circumference of the Hips, Waist and Upper Abdomen for Individuals With a Body Mass Index (BMI) of 30 to 40 kg/m2
1 other identifier
interventional
53
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable obesity
Started Mar 2013
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 27, 2013
CompletedFirst Posted
Study publicly available on registry
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedResults Posted
Study results publicly available
December 11, 2015
CompletedDecember 11, 2015
November 1, 2015
1.1 years
March 27, 2013
July 10, 2015
November 7, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Difference in the Proportion of Primary Outcome Successes Between Treatment Groups for Change in Combined Circumference Measurements
Individual measurements in inches of the waist, hips and upper abdomen were combined to calculate a total body circumference measurement. Change in combined circumference measurement from baseline to 4 weeks was calculated for each subject. Individual subject success was defined as a change of 3.0 inches or more in the combined circumference measurement across the evaluation period. A decrease in combined circumference measurement is positive for individual subject success. An increase in combined circumference measurement is negative for individual subject success. Overall study success was defined as a 40% or greater difference between the proportion of individual successes in each treatment group.
Baseline and 4 Weeks
Change in Combined Circumference Measurement
Individual measurements in inches of the waist, hips and upper abdomen were combined to calculate a total combined body circumference measurement. Change in combined circumference measurement is calculated as the difference in circumference measurements from baseline to endpoint (4 weeks). A negative (-) change indicates a decrease in circumference and is positive for study success. A positive (+) change indicates an increase in circumference and is negative for study success.
Baseline and 4 Weeks
Other Outcomes (1)
Subject Satisfaction With Procedure Outcome
4 Weeks
Study Arms (2)
Erchonia Obesity Laser
ACTIVE COMPARATORThe Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW), 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
Placebo Laser
PLACEBO COMPARATORLaser device emitting sham green light that has no therapeutic effect.
Interventions
10 independent 17 milliwatts 532 nm green diode lasers
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Surgeons Inc.
Noblesville, Indiana, 46060, United States
Bloomfield Laser and Cosmetic Surgery Center
Bloomfield Hills, Michigan, 48302, United States
Related Publications (1)
Roche GC, Shanks S, Jackson RF, Holsey LJ. Low-Level Laser Therapy for Reducing the Hip, Waist, and Upper Abdomen Circumference of Individuals with Obesity. Photomed Laser Surg. 2017 Mar;35(3):142-149. doi: 10.1089/pho.2016.4172. Epub 2016 Dec 9.
PMID: 27935737DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Consultant
- Organization
- Regulatory Insight, Inc.
Study Officials
- STUDY DIRECTOR
Steven Shanks
Erchonia Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2013
First Posted
April 1, 2013
Study Start
March 1, 2013
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
December 11, 2015
Results First Posted
December 11, 2015
Record last verified: 2015-11