Body ContouringNCT01292538
Study of the Effectiveness of Green Diode Laser Light on Body Shaping
A study testing Erchonia GLS in people with Body Contouring, run by Erchonia Corporation at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Contouring
- What is being tested?
- Erchonia GLS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2011to Jun 2012
- 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) 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Bloomfield Laser and Cosmetic Surgery Center
Bloomfield Hills, Michigan, 48302
Surgeon's Inc.
Marion, Indiana, 46952
About this study
Official title: A Double-blind, Placebo-controlled Randomized Evaluation of the Effect of the Erchonia Scanner Device (GLS) Green Diode on Body Contouring of the Waist, Hips and Thighs
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.
Read the detailed description
Weight loss and body contouring are large, constantly-growing fields of cosmetic surgery. However, while the demand for body shaping procedures is constantly on the rise, so is the demand for such procedures to be performed more quickly, simply and most importantly, less invasively; hence the growing popularity of non- to minimally-invasive cosmetic surgery procedures. In 2005, more than 7.5 million minimally-invasive cosmetic procedures were performed, a 35% increase from 2000.
In recent years, Erchonia Corporation, a manufacturer of low level lasers, has developed a dual-diode laser that emits 532 nm and 635nm collimated line-generated beams to emulsify fat. In August, 2010, the Erchonia® ML Scanner (MLS) 635nm was cleared by FDA for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. It was determined that the biochemical effect of the Erchonia® MLS stimulates the mitochondria of the adipocyte cells which in turn increases the production of ATP. The newly synthesized ATP triggers the up-regulation of cyclic adenosine monophosphate (cAMP). cAMP has been shown to stimulate cytoplasmic lipase, triggering the conversion of triglycerides into fatty acids and glycerol that can easily pass through the cell membrane. The transitory pore is evidence that the laser is allowing for the movement of fatty acids, glycerol, and triglycerides to pass across the membrane and into extra-cellular space. Through vasodilation of nearby blood vessels and arteries, oxidization of the triglycerides and fatty acids occurs within the extra-cellular space.
This pilot study will apply the Erchonia® MLS employing 532 nm green diodes in lieu of 635 nm red diodes to compare the results to those attained using the 635 nm diodes. The Sponsor believes the use of 532 nm diodes may prove as effective as 635 nm diodes combined with a reduction in total procedure administration time from 40 to 30 minutes. It is the goal of this study to evaluate this hypothesis.
- Conditions
- Body Contouring
- Being tested
- Erchonia GLS, Placebo laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erchonia GLSDevice
532 nm green diode low level laser light device
Placebo laserDevice
Sham light output with no therapeutic benefit
| Study group | Role | What they receive |
|---|---|---|
| Erchonia GLS 532nm | Experimental | 532nm green laser light therapy. Receives: Device: Erchonia GLS |
| Placebo laser | Sham comparator | Sham light output with no therapeutic benefit Receives: Device: Placebo laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined Circumference in Inches of the Waist, Hips and Bilateral Thighs
Mean change in total combined circumference inches of the waist, hips and bilateral thighs from baseline to endpoint evaluation.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJun 2012
- Study completionJun 2012
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.
- Other trials for Body ContouringStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erchonia Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory C Roche, MD, FACS, Principal investigatorRobert F Jackson, MD, FACS, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292538
- Sponsor's protocol ID
- EC-GREEN001
- Status last verified
- Jan 2020
- First submitted
- 8 Feb 2011
- Last updated
- 10 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. 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 Scanner Device (GLS) Green Diode on Body Contouring of the Waist, Hips and Thighs
- ClinicalTrials.gov ID
- NCT01292538
- Acronym / sponsor ID
- EC-GREEN001
- Conditions
- Body Contouring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Erchonia CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 9 Feb 2011 (estimated)
- Results
- Posted 3 Jun 2014
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 if 532nm green diode laser light is effective in body contouring of the waist, hips and thighs.
Detailed description
Weight loss and body contouring are large, constantly-growing fields of cosmetic surgery. However, while the demand for body shaping procedures is constantly on the rise, so is the demand for such procedures to be performed more quickly, simply and most importantly, less invasively; hence the growing popularity of non- to minimally-invasive cosmetic surgery procedures. In 2005, more than 7.5 million minimally-invasive cosmetic procedures were performed, a 35% increase from 2000.
In recent years, Erchonia Corporation, a manufacturer of low level lasers, has developed a dual-diode laser that emits 532 nm and 635nm collimated line-generated beams to emulsify fat. In August, 2010, the Erchonia® ML Scanner (MLS) 635nm was cleared by FDA for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. It was determined that the biochemical effect of the Erchonia® MLS stimulates the mitochondria of the adipocyte cells which in turn increases the production of ATP. The newly synthesized ATP triggers the up-regulation of cyclic adenosine monophosphate (cAMP). cAMP has been shown to stimulate cytoplasmic lipase, triggering the conversion of triglycerides into fatty acids and glycerol that can easily pass through the cell membrane. The transitory pore is evidence that the laser is allowing for the movement of fatty acids, glycerol, and triglycerides to pass across the membrane and into extra-cellular space. Through vasodilation of nearby blood vessels and arteries, oxidization of the triglycerides and fatty acids occurs within the extra-cellular space.
This pilot study will apply the Erchonia® MLS employing 532 nm green diodes in lieu of 635 nm red diodes to compare the results to those attained using the 635 nm diodes. The Sponsor believes the use of 532 nm diodes may prove as effective as 635 nm diodes combined with a reduction in total procedure administration time from 40 to 30 minutes. It is the goal of this study to evaluate this hypothesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erchonia GLS 532nm | Experimental | Device: Erchonia GLS532nm green laser light therapy. |
| Placebo laser | Sham comparator | Device: Placebo laserSham light output with no therapeutic benefit |
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) 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.
Key exclusion criteria (17 listed)
- 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.
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 GLS532 nm green diode low level laser light device | Device | Erchonia GLS 532nm |
| Placebo laserSham light output with no therapeutic benefit | Device | Placebo laser |
Primary outcome
Combined Circumference in Inches of the Waist, Hips and Bilateral Thighs
Time frame: 2 weeks
Mean change in total combined circumference inches of the waist, hips and bilateral thighs from baseline to endpoint evaluation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gregory C Roche, MD, FACS principal investigator
Robert F Jackson, MD, FACS principal investigator
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 GLS in people with Body Contouring, 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 17 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 10 Feb 2020. 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 3 Jun 2014). 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?
Combined Circumference in Inches of the Waist, Hips and Bilateral Thighs (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2020.