Body ContouringNCT00738426
Study of Low Level Laser Therapy for Body Contouring
A study testing Erchonia ML Scanner (MLS) in people with Body Contouring, run by Erchonia Corporation at 3 sites in United States.
Trial summary
The purpose of this study is to determine whether green diode low level laser therapy is effective for 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 ML Scanner (MLS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2007to Jul 2008
- 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
- indicated for liposuction for the removal of localized deposits of adipose tissues that do not respond to diet and exercise; specifically in the areas of the waist, hips and bilateral thighs.
- willing and able to abstain from partaking in any treatment other than the study procedure (existing or new) to promote body contouring and/or weight loss during the course of study participation.
- willing and able to maintain regular diet and exercise regimen without during study participation.
- 18 to 65 years.
- Male or female.
Who cannot join
- Body Mass Index (BMI) of 30 kg/m² or greater.
- Diabetes dependent on insulin or oral hypoglycemic medications.
- known cardiovascular disease.
- cardiac surgeries, pacemakers.
- excessive alcohol consumption.
- prior surgical intervention for body sculpting/weight loss.
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- medical, physical, or other contraindications for body sculpting/weight loss.
- current use of medication(s) known to affect weight levels and/or to cause bloating or swelling and for which abstinence during the course of study participation is not safe or medically prudent.
- 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.
- pregnant, breast feeding, or planning pregnancy prior to study end.
- serious mental health illness; 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 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 research in the past 90 days.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Dr. Gregory C. Roche
Bloomfield Hills, Michigan, 48302
Cosmetic Surgery
Marion, Indiana, 46952
Douglas D. Dedo, MD, FACS
Palm Beach Gardens, Florida, 33410
About this study
Official title: A Double-Blind, Placebo-Controlled Randomized Evaluation of the Effect of the Erchonia ML Scanner (MLS) on Body Contouring of the Waist, Hips and Thighs Clinical Study Protocol
The purpose of this study is to determine whether green diode low level laser therapy is effective for 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. According to the American Society of Plastic Surgeons (ASPS) statistics, more than 324,000 liposuction procedures, 233,000 eyelid surgeries and 114,000 facelift procedures were performed in 2004 in the United States alone. 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. Cosmetic surgery patients are no longer satisfied with procedures that require general anesthesia, pose a multitude of potentially serious risks and complications and that require several weeks of recovery time. 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. Consequently, patients and physicians alike are continually searching for non-invasive alternatives to traditional cosmetic procedures such as liposuction that are efficient, safe and effective.
- Conditions
- Body Contouring
- Being tested
- Erchonia ML Scanner (MLS), Sham device
- Keywords
- non-invasive body contouring of waists hips and thighs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erchonia ML Scanner (MLS)Device
Red diode low level laser light energy.
Sham deviceDevice
non-therapeutic light energy output
| Study group | Role | What they receive |
|---|---|---|
| Erchonia ML Scanner (MLS) | Active comparator | Red diode low level laser light energy Receives: Device: Erchonia ML Scanner (MLS) |
| Sham device | Sham comparator | non-therapeutic sham light output Receives: Device: Sham device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of the Reduction of at Least 3.0 Inches Off Their Combined Waist-hips-thighs Circumference.
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 posted20 Aug 2008 (estimated)
- Study startOct 2007
- Primary completionJun 2008
- Study completionJul 2008
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
- 72 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
- NCT00738426
- Sponsor's protocol ID
- BCL-001
- Status last verified
- Jan 2020
- First submitted
- 18 Aug 2008
- 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 ML Scanner (MLS) on Body Contouring of the Waist, Hips and Thighs Clinical Study Protocol
- ClinicalTrials.gov ID
- NCT00738426
- Acronym / sponsor ID
- BCL-001
- Conditions
- Body Contouring
- Keywords
- non-invasive body contouring of waists hips and thighs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Erchonia CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 20 Aug 2008 (estimated)
- Results
- Posted 2 May 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 whether green diode low level laser therapy is effective for body contouring of the waist, hips and thighs.
Detailed description
Weight loss and body contouring are large, constantly-growing fields of cosmetic surgery. According to the American Society of Plastic Surgeons (ASPS) statistics, more than 324,000 liposuction procedures, 233,000 eyelid surgeries and 114,000 facelift procedures were performed in 2004 in the United States alone. 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. Cosmetic surgery patients are no longer satisfied with procedures that require general anesthesia, pose a multitude of potentially serious risks and complications and that require several weeks of recovery time. 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. Consequently, patients and physicians alike are continually searching for non-invasive alternatives to traditional cosmetic procedures such as liposuction that are efficient, safe and effective.
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 ML Scanner (MLS) | Active comparator | Device: Erchonia ML Scanner (MLS)Red diode low level laser light energy |
| Sham device | Sham comparator | Device: Sham devicenon-therapeutic sham light output |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- indicated for liposuction for the removal of localized deposits of adipose tissues that do not respond to diet and exercise; specifically in the areas of the waist, hips and bilateral thighs.
- willing and able to abstain from partaking in any treatment other than the study procedure (existing or new) to promote body contouring and/or weight loss during the course of study participation.
- willing and able to maintain regular diet and exercise regimen without during study participation.
- 18 to 65 years.
- Male or female.
Key exclusion criteria (16 listed)
- Body Mass Index (BMI) of 30 kg/m² or greater.
- Diabetes dependent on insulin or oral hypoglycemic medications.
- known cardiovascular disease.
- cardiac surgeries, pacemakers.
- excessive alcohol consumption.
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 ML Scanner (MLS)Red diode low level laser light energy. | Device | Erchonia ML Scanner (MLS) |
| Sham devicenon-therapeutic light energy output | Device | Sham device |
Primary outcome
Incidence of the Reduction of at Least 3.0 Inches Off Their Combined Waist-hips-thighs Circumference.
Time frame: 2 weeks
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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erchonia ML Scanner (MLS) in people with Body Contouring, run by Erchonia Corporation at 3 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 5 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 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 3 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 2 May 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?
Incidence of the Reduction of at Least 3.0 Inches Off Their Combined Waist-hips-thighs Circumference. (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.