Weight LossNCT01292564
Study to See How Low Level Laser Light Affects Subcutaneous Fat Around the Hips and Waist
A study testing Erchonia MLS in people with Weight Loss, run by Erchonia Corporation at 1 site in United States.
Trial summary
The purpose of this pilot study is to demonstrate the anatomical modulation of subcutaneous fat across the waist and hips that occurs through application of the Erchonia® ML Scanner (MLS) Laser manufactured for non-invasive body contouring of the waist and hips. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- Erchonia MLS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Subject indicated for liposuction or use of liposuction techniques for the removal of localized deposits of adipose tissues; specifically for the indication of body contouring in the areas of the waist and hips. (As per the American Academy of Cosmetic Surgery's 2006 Guidelines for Liposuction Surgery).
- Body Mass Index (BMI) of 28 to 43 kg/m², inclusive.
- It is deemed safe for the subject to undergo a MRI procedure based on the MRI screening questionnaire.
- 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) is less than 28 kg/m² or greater than 43 kg/m².
- Diabetes dependent on insulin or oral hypoglycemic medications.
- Known cardiovascular disease.
- Prior cardiac surgery.
- Prior surgical intervention for body sculpting/weight loss.
- Medical, physical, or other contraindications for body sculpting/weight loss.
Show all 15Show fewer
- Current use of medication(s) known to affect weight levels/bloating/swelling and for which abstinence during study participation is not safe or medically prudent.
- Any medical condition known to affect weight levels/cause bloating/swelling.
- Diagnosis of, and/or taking medication for, irritable bowel syndrome.
- Active infection, wound or other external trauma to the laser treatment area.
- 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 and/or body shape issues.
- participation in research in the past 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
American Laser Centers
Fox River Grove, Illinois, 60021
About this study
Official title: An Evaluation of the Effect of the Erchonia ML Scanner (MLS) as Applied to Body Contouring of the Waist and Hips on Fat Emulsification Pilot Study.
The purpose of this pilot study is to demonstrate the anatomical modulation of subcutaneous fat across the waist and hips that occurs through application of the Erchonia® ML Scanner (MLS) Laser manufactured for non-invasive body contouring of the waist and hips.
Read the detailed description
Laser therapy provides an alternative therapeutic regimen for the reduction of subcutaneous tissue volume. Although the biochemical mechanism is not yet fully understood, histological studies clearly and effectively identify the formation of the transitory pore and subsequent cell collapse immediately following laser irradiation. More importantly, a placebo-controlled, randomized, double-blind clinical investigation using the Erchonia MLS with 67 enrolled participants revealed a statistically significant reduction of overall circumference measurements of the waist, hip, and thighs following two weeks of treatment, resulting in Food and Drug Administration (FDA) clearance for the indication.
Laser therapy operates under the principle of photochemistry, activating and/or suppressing natural biochemical processes. Because Low Level Laser Therapy (LLLT) does not induce cellular apoptosis, there is no upregulation of pro-inflammatory cytokines nor is there a large burden placed on the lymphatic system. The fatty material secreted from the adipocytes following laser irradiation are absorbed by the lymphatic system, broken down by the liver, and naturally secreted. Fatty acids released are bound to albumin, and are transported through the circulatory system to the liver to undergo fatty acid oxidation. The triglycerides released are bound as lipoproteins and transported to the liver to be processed. Moreover, a lipase known as lipoprotein lipase, has been demonstrated to breakdown emulsified triglycerides; therefore breaking the molecule down into three fatty acids and one glycerol molecule. The most important aspect of laser therapy is that cellular apoptosis is not induced. The fatty material being evacuated from the cell must be absorbed by the lymphatic system, and because laser therapy does not destroy the cell, the complex organelles and the entire cell structure will not be absorbed by the lymphatic system. It is not well understood how much the lymphatic system can absorb; therefore, creating a mass amount of cellular debris by destroying adipose tissue may result in serious long term effects. Moreover, adipose tissue is not just composed of fat storing cells; there is also a collection of immune cells, fibroblasts, vessels, and stromal stem cells. By creating the transitory pore in the fat storing cell only, the viability of the surrounding, non-fat storing cells is preserved.
The purpose of this pilot study is to demonstrate and document the anatomical modulation of subcutaneous fat across the waist and hips that occurs through application of the Erchonia® ML Scanner (MLS) Laser manufactured for non-invasive body contouring of the waist and hips.
- Conditions
- Weight Loss
- Being tested
- Erchonia MLS, Placebo Laser
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erchonia MLSDevice
The Erchonia MLS emits 635 nm low level laser light.
Placebo LaserDevice
The Placebo Laser looks identical to the Erchonia MLS Laser but emits no therapeutic light.
| Study group | Role | What they receive |
|---|---|---|
| Erchonia MLS | Active comparator | The Erchonia MLS emits 635 nm low level laser light. Receives: Device: Erchonia MLS |
| Placebo Laser | Placebo comparator | The Placebo Laser looks identical to the Erchonia MLS Laser but emits no therapeutic light. Receives: Device: Placebo Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat Surface area (cm2) & projected fat volume (cm3) determined through MRI analysis
Measured: 2 weeks
Secondary outcomes (3)
Body Mass Index (BMI)
Measured: 2 weeks
Hip circumference measurement in cm
Measured: 2 weeks
Waist circumference measurement
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 completionAug 2012
- Study completionAug 2012
Why it stopped: Insufficient resources at test site for recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erchonia Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Turok, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292564
- Sponsor's protocol ID
- EC-MRI001
- Status last verified
- May 2014
- First submitted
- 8 Feb 2011
- Last updated
- 9 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Effect of the Erchonia ML Scanner (MLS) as Applied to Body Contouring of the Waist and Hips on Fat Emulsification Pilot Study.
- ClinicalTrials.gov ID
- NCT01292564
- Acronym / sponsor ID
- EC-MRI001
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient resources at test site for recruitment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Erchonia CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 9 Feb 2011 (estimated)
- Results
- Not posted in the source record
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 pilot study is to demonstrate the anatomical modulation of subcutaneous fat across the waist and hips that occurs through application of the Erchonia® ML Scanner (MLS) Laser manufactured for non-invasive body contouring of the waist and hips.
Detailed description
Laser therapy provides an alternative therapeutic regimen for the reduction of subcutaneous tissue volume. Although the biochemical mechanism is not yet fully understood, histological studies clearly and effectively identify the formation of the transitory pore and subsequent cell collapse immediately following laser irradiation. More importantly, a placebo-controlled, randomized, double-blind clinical investigation using the Erchonia MLS with 67 enrolled participants revealed a statistically significant reduction of overall circumference measurements of the waist, hip, and thighs following two weeks of treatment, resulting in Food and Drug Administration (FDA) clearance for the indication.
Laser therapy operates under the principle of photochemistry, activating and/or suppressing natural biochemical processes. Because Low Level Laser Therapy (LLLT) does not induce cellular apoptosis, there is no upregulation of pro-inflammatory cytokines nor is there a large burden placed on the lymphatic system. The fatty material secreted from the adipocytes following laser irradiation are absorbed by the lymphatic system, broken down by the liver, and naturally secreted. Fatty acids released are bound to albumin, and are transported through the circulatory system to the liver to undergo fatty acid oxidation. The triglycerides released are bound as lipoproteins and transported to the liver to be processed. Moreover, a lipase known as lipoprotein lipase, has been demonstrated to breakdown emulsified triglycerides; therefore breaking the molecule down into three fatty acids and one glycerol molecule. The most important aspect of laser therapy is that cellular apoptosis is not induced. The fatty material being evacuated from the cell must be absorbed by the lymphatic system, and because laser therapy does not destroy the cell, the complex organelles and the entire cell structure will not be absorbed by the lymphatic system. It is not well understood how much the lymphatic system can absorb; therefore, creating a mass amount of cellular debris by destroying adipose tissue may result in serious long term effects. Moreover, adipose tissue is not just composed of fat storing cells; there is also a collection of immune cells, fibroblasts, vessels, and stromal stem cells. By creating the transitory pore in the fat storing cell only, the viability of the surrounding, non-fat storing cells is preserved.
The purpose of this pilot study is to demonstrate and document the anatomical modulation of subcutaneous fat across the waist and hips that occurs through application of the Erchonia® ML Scanner (MLS) Laser manufactured for non-invasive body contouring of the waist and hips.
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 MLS | Active comparator | Device: Erchonia MLSThe Erchonia MLS emits 635 nm low level laser light. |
| Placebo Laser | Placebo comparator | Device: Placebo LaserThe Placebo Laser looks identical to the Erchonia MLS Laser but emits no therapeutic light. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject indicated for liposuction or use of liposuction techniques for the removal of localized deposits of adipose tissues; specifically for the indication of body contouring in the areas of the waist and hips. (As per the American Academy of Cosmetic Surgery's 2006 Guidelines for Liposuction Surgery).
- Body Mass Index (BMI) of 28 to 43 kg/m², inclusive.
- It is deemed safe for the subject to undergo a MRI procedure based on the MRI screening questionnaire.
- 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 (15 listed)
- Body Mass Index (BMI) is less than 28 kg/m² or greater than 43 kg/m².
- Diabetes dependent on insulin or oral hypoglycemic medications.
- Known cardiovascular disease.
- Prior cardiac surgery.
- Prior surgical intervention 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 MLSThe Erchonia MLS emits 635 nm low level laser light. | Device | Erchonia MLS |
| Placebo LaserThe Placebo Laser looks identical to the Erchonia MLS Laser but emits no therapeutic light. | Device | Placebo Laser |
Primary outcome
Fat Surface area (cm2) & projected fat volume (cm3) determined through MRI analysis
Time frame: 2 weeks
3 secondary outcomes
Body Mass Index (BMI)
Time frame: 2 weeks
Hip circumference measurement in cm
Time frame: 2 weeks
Waist circumference measurement
Time frame: 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2014.
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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.
David Turok, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erchonia MLS in people with Weight Loss, run by Erchonia Corporation at 1 site 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 5 inclusion and 15 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: withdrawn, as of the sponsor's last update on 9 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Fat Surface area (cm2) & projected fat volume (cm3) determined through MRI analysis (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 9 May 2014; AzTrials last refreshed its copy on 28 Oct 2026.