ObesityNCT01821352
Study of Low Level Laser Therapy to Reduce Body Circumference in Obese Individuals
A study testing Erchonia Obesity Laser in people with Obesity, run by Erchonia Corporation at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Erchonia Obesity Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2013to Apr 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 16Show fewer
- 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.
- Participation in a clinical study or other type of research in the past 30 days
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bloomfield Laser and Cosmetic Surgery Center
Bloomfield Hills, Michigan, 48302
Surgeons Inc.
Noblesville, Indiana, 46060
About this study
Official title: 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
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.
Read the detailed description
The American Society of Plastic Surgeons (ASPS) 2011 report states that the market for cosmetic procedures has shown significant growth over the past two years, with 13.8 million cosmetic plastic surgery procedures performed in the United States in 2011, up 5% since 2010. While surgical cosmetic procedures did increase significantly from 2010 to 2011, the overall growth in cosmetic procedures is being primarily driven by a substantial rise in minimally-invasive procedures. Cosmetic minimally-invasive procedures increased 6%, with nearly 12.2 million cosmetic minimally-invasive procedures having been performed in 2011. This highlights the growing consumer demand for non- or minimally-invasive cosmetic procedures that do not involve surgical procedures such as liposuction and the associated risks, potential complications and lengthy and painful recovery processes.
Low level laser light therapy, such as that to be provided through application of the Erchonia® Obesity Laser in this clinical study protocol, offers a simple, non-invasive, safe, effective and side-effect free alternative to achieving body circumference reduction.
Justification for this assertion of anticipated safety and effectiveness of the application of the Erchonia® Obesity Laser for the reduction of body circumference is found through three FDA clearances for Erchonia® Low Level Laser devices for body circumference reduction indications, as follows:
K123237 (532 nm green light diodes): Erchonia® Zerona™ 2.0 Laser: is indicated for use as a non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist, and thighs.
K121695 \& K082609 (635 nm red light diodes): Erchonia® ML Scanner (MLS) \& Erchonia® Zerona: is indicated for use as a non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist, and thighs.
K121690 \& K120257 (635 nm red light diodes): Erchonia® MLS, Zerona, Zerona-AD: is indicated for use as a non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of the upper arms.
Therefore, Erchonia low level lasers have been determined safe and effective by the FDA for application for body circumference reduction indications for multiple body areas, such that evaluation of application of the Erchonia Obesity Laser to reducing body circumference in more overweight individuals is a natural extension of its proven and accepted application for body circumference reduction purposes.
- Conditions
- Obesity
- Being tested
- Erchonia Obesity Laser, Placebo Laser
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erchonia Obesity LaserDevice
10 independent 17 milliwatts 532 nm green diode lasers
Placebo LaserDevice
Emits light that has no therapeutic effect
| Study group | Role | What they receive |
|---|---|---|
| Erchonia Obesity Laser | Active comparator | The 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. Receives: Device: Erchonia Obesity Laser |
| Placebo Laser | Placebo comparator | Laser device emitting sham green light that has no therapeutic effect. Receives: Device: Placebo Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erchonia Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Shanks, Study director, Erchonia Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01821352
- Sponsor's protocol ID
- EC_OL_001
- Status last verified
- Nov 2015
- First submitted
- 27 Mar 2013
- Last updated
- 11 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 27935737
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01821352
- Acronym / sponsor ID
- EC_OL_001
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Erchonia CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 1 Apr 2013 (estimated)
- Results
- Posted 11 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The American Society of Plastic Surgeons (ASPS) 2011 report states that the market for cosmetic procedures has shown significant growth over the past two years, with 13.8 million cosmetic plastic surgery procedures performed in the United States in 2011, up 5% since 2010. While surgical cosmetic procedures did increase significantly from 2010 to 2011, the overall growth in cosmetic procedures is being primarily driven by a substantial rise in minimally-invasive procedures. Cosmetic minimally-invasive procedures increased 6%, with nearly 12.2 million cosmetic minimally-invasive procedures having been performed in 2011. This highlights the growing consumer demand for non- or minimally-invasive cosmetic procedures that do not involve surgical procedures such as liposuction and the associated risks, potential complications and lengthy and painful recovery processes.
Low level laser light therapy, such as that to be provided through application of the Erchonia® Obesity Laser in this clinical study protocol, offers a simple, non-invasive, safe, effective and side-effect free alternative to achieving body circumference reduction.
Justification for this assertion of anticipated safety and effectiveness of the application of the Erchonia® Obesity Laser for the reduction of body circumference is found through three FDA clearances for Erchonia® Low Level Laser devices for body circumference reduction indications, as follows:
K123237 (532 nm green light diodes): Erchonia® Zerona™ 2.0 Laser: is indicated for use as a non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist, and thighs.
K121695 \& K082609 (635 nm red light diodes): Erchonia® ML Scanner (MLS) \& Erchonia® Zerona: is indicated for use as a non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist, and thighs.
K121690 \& K120257 (635 nm red light diodes): Erchonia® MLS, Zerona, Zerona-AD: is indicated for use as a non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of the upper arms.
Therefore, Erchonia low level lasers have been determined safe and effective by the FDA for application for body circumference reduction indications for multiple body areas, such that evaluation of application of the Erchonia Obesity Laser to reducing body circumference in more overweight individuals is a natural extension of its proven and accepted application for body circumference reduction purposes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erchonia Obesity Laser | Active comparator | Device: Erchonia Obesity LaserThe 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 comparator | Device: Placebo LaserLaser device emitting sham green light that has no therapeutic effect. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erchonia Obesity Laser10 independent 17 milliwatts 532 nm green diode lasers | Device | Erchonia Obesity Laser |
| Placebo LaserEmits light that has no therapeutic effect | Device | Placebo Laser |
Primary outcome
Difference in the Proportion of Primary Outcome Successes Between Treatment Groups for Change in Combined Circumference Measurements
Time frame: Baseline and 4 Weeks
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.
Change in Combined Circumference Measurement
Time frame: Baseline and 4 Weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27935737Roche 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Shanks study director
Erchonia Corporation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erchonia Obesity Laser in people with Obesity, run by Erchonia Corporation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the Proportion of Primary Outcome Successes Between Treatment Groups for Change in Combined Circumference Measurements (time frame: Baseline and 4 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01821352, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2015; AzTrials last refreshed its copy on 6 Nov 2026.