PainNCT00927277
Low Level Laser Light Therapy as an Aid to Liposuction
A study testing Erchonia(R) LipoLASER PL; Erchonia(R) EML Laser and Erchonia(R) LipoLASER PL in people with Pain, run by Erchonia Corporation.
Trial summary
The purpose of this study is to determine whether low level laser therapy can help the recovery process for the procedure of liposuction of the thighs, hips and stomach. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Erchonia(R) LipoLASER PL; Erchonia(R) EML Laser and Erchonia(R) LipoLASER PL
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Mar 2003to Mar 2004
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Prior to partaking in the clinical study qualification evaluation, an individual must have already:
- qualified as a patient for liposuction according to the American Society of Liposuction Surgery (ASLSS) and the American Academy of Cosmetic Surgery (AACS) 2000 Liposuction Guidelines.
- been deemed suitable for undergoing anesthesia according to the American Society of Anesthesiologists: Preanesthesia Evaluation guidelines: Basic Standards For Preanesthesia Care (Approved by House of Delegates on October 14, 1987).
- Signed the physician's standard informed consent form for the liposuction procedure itself.
- Signed clinical study informed consent form.
- Liposuction procedure intended for the removal of localized deposits of adipose tissue for the purpose of body contouring.
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- Body Mass Index (BMI) in kg/m2 of less than 30 (non-obese).
- Localized areas of protruding fat deemed suitable for body contouring liposuction according to the investigator's professional training and experience as for a patient presenting with the same profile and not being considered for participation in the study.
- Areas of treatment to include only one or more of the right and/or left sides of the stomach, thigh, and hips.
- 'Overall firm elastic skin,' as defined by passing of the "snap test" for each intended treatment area.
- American Society of Anesthesiology (ASA) Physical Status Classification System rating of P1: a normal healthy patient or P2: a patient with mild systemic disease, as determined by standard physical examination.
- Suitable for general intubation anesthesia.
- 18 to 55 years, inclusive.
Who cannot join
- Liposuction procedure intended for the treatment of diseases, such as lipomas, gynecomastia, pseudogynecomastia, lipodystrophy and axillary hyperhydrosis; for the reconstruction of the skin and subtissues in flap elevations, subcutaneous debulking, flap movement or other conditions; to obtain fat for fat transfer (for such purposes as augmentation, correction of scar defects, etc.), and for weight loss.
- ASA Physical Status Classification System rating of P3 to P5.
- Use of narcotics, opiates, steroids and/or NSAIDs within one week prior to surgery.
- Any prior surgery to any of the area(s) to receive liposuction.
- Active infection or wound in any part of the body, including the intended areas of treatment.
- Arthritis or other disorders or injury that directly affect the areas to be treated, including any implants such as pins.
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- History of thrombotic events.
- History of neurologic disorder e.g. sensory loss or dysthesia in any of the area(s) to be treated.
- Diabetes.
- Immuno-compromised state, e.g., HIV infection, radiation, chemo or other cancer therapy within the last 6 months.
- Potential bleeding tendencies due to the use of aspirin, non-steroidal anti-inflammatory drugs, estrogen, Vitamin E, herbal supplements such as ginseng, ginger.
- Potential hypercoagulability, e.g., tamoxifen therapy, cancer, recent significant trauma, dehydration.
- Developmental disabilities that affect the ability to read and/or understand the consent form and any other information that may be required from the subject.
- Significant psychological disorder(s) for which treatment has become necessary, including anxiety and depression; psychiatric hospitalization.
- Pregnancy or lactation.
- Involvement in litigation and/or receiving disability benefits related to any kind of disability, injury, or other problem in any one or more of the area(s) to receive liposuction.
- Participation in research during the prior 90 days.
About this study
Official title: Erchonia Medical, Inc., Erchonia EML Laser Liposuction Clinical Study V Protocol
The purpose of this study is to determine whether low level laser therapy can help the recovery process for the procedure of liposuction of the thighs, hips and stomach.
Read the detailed description
The Erchonia EML Laser is designed to administer low level laser therapy (LLLT). It has been hypothesized that LLLT may reduce pain and promote nerve regeneration through the speculated anti-inflammatory and immune enhancement properties of the therapy. Prior research has indicated LLLT to be a potentially safe and effective means of reducing pain. This clinical study was designed to evaluate the potential of the Erchonia EML Laser in offering a novel means of delivering LLLT to reduce pain and enhance healing following liposuction.
- Conditions
- Pain
- Being tested
- Erchonia(R) LipoLASER PL; Erchonia(R) EML Laser, Erchonia(R) LipoLASER PL
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erchonia(R) LipoLASER PL; Erchonia(R) EML LaserDevice
The Erchonia(R) EML Laser is a low level laser light therapy medical device that was applied during the liposuction procedure, by emitting 1 mw of red (635nm wavelength) light via a Class II electric laser diode energy source (CDRH classification). The fluence is considered to be at 10.8 joules per area treated.
Erchonia(R) LipoLASER PLDevice
| Study group | Role | What they receive |
|---|---|---|
| placebo laser | Placebo comparator | inactive light on the laser device. Receives: Device: Erchonia(R) LipoLASER PL |
| Erchonia (R) LipoLASER PL | Active comparator | The Erchonia(R) LipoLASER PL is a low level laser light therapy medical device that was applied during the liposuction procedure, by emitting 1 mw of red (635nm wavelength) light via a Class II electric laser diode energy source (CDRH classification). The fluence is considered to be at 10.8 joules per area treated. Receives: Device: Erchonia(R) LipoLASER PL; Erchonia(R) EML Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject self-reported Degree of Pain rating on the standardized 0-100 Visual Analogue Scale (VAS) at 24 hours post-surgery.
Measured: 24 hours
Secondary outcomes (6)
Ease of the process of fat extraction during the liposuction procedure
Measured: immediately post surgery
Emulsification (consistency) of extracted fat
Measured: immediately post surgery
Amount of time spent by volume of fat removed
Measured: Immediately post surgery
Degree of swelling at the surgical site
Measured: 7 days post surgery
Subject self-reported degree of post-surgical pain
Measured: 7, 14 and 28 days post surgery
Use of recovery pain medication
Measured: Through the 1st 7 post-surgical days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2009 (estimated)
- Study startMar 2003
- Primary completionMar 2004
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erchonia Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Robert F Jackson, MD, FACS, Principal investigatorGregory Roche, DO, Principal investigatorKimberly Butterwick, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927277
- Sponsor's protocol ID
- ELIPO-001
- Status last verified
- Jun 2009
- First submitted
- 22 Jun 2009
- Last updated
- 26 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erchonia Medical, Inc., Erchonia EML Laser Liposuction Clinical Study V Protocol
- ClinicalTrials.gov ID
- NCT00927277
- Acronym / sponsor ID
- ELIPO-001
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Erchonia CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2003
- Primary completion
- Mar 2004 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 24 Jun 2009 (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 study is to determine whether low level laser therapy can help the recovery process for the procedure of liposuction of the thighs, hips and stomach.
Detailed description
The Erchonia EML Laser is designed to administer low level laser therapy (LLLT). It has been hypothesized that LLLT may reduce pain and promote nerve regeneration through the speculated anti-inflammatory and immune enhancement properties of the therapy. Prior research has indicated LLLT to be a potentially safe and effective means of reducing pain. This clinical study was designed to evaluate the potential of the Erchonia EML Laser in offering a novel means of delivering LLLT to reduce pain and enhance healing following liposuction.
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 |
|---|---|---|
| placebo laser | Placebo comparator | Device: Erchonia(R) LipoLASER PLinactive light on the laser device. |
| Erchonia (R) LipoLASER PL | Active comparator | Device: Erchonia(R) LipoLASER PL; Erchonia(R) EML LaserThe Erchonia(R) LipoLASER PL is a low level laser light therapy medical device that was applied during the liposuction procedure, by emitting 1 mw of red (635nm wavelength) light via a Class II electric laser diode energy source (CDRH classification). The fluence is considered to be at 10.8 joules per area treated. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Prior to partaking in the clinical study qualification evaluation, an individual must have already:
- qualified as a patient for liposuction according to the American Society of Liposuction Surgery (ASLSS) and the American Academy of Cosmetic Surgery (AACS) 2000 Liposuction Guidelines.
- been deemed suitable for undergoing anesthesia according to the American Society of Anesthesiologists: Preanesthesia Evaluation guidelines: Basic Standards For Preanesthesia Care (Approved by House of Delegates on October 14, 1987).
- Signed the physician's standard informed consent form for the liposuction procedure itself.
- Signed clinical study informed consent form.
Key exclusion criteria (17 listed)
- Liposuction procedure intended for the treatment of diseases, such as lipomas, gynecomastia, pseudogynecomastia, lipodystrophy and axillary hyperhydrosis; for the reconstruction of the skin and subtissues in flap elevations, subcutaneous debulking, flap movement or other conditions; to obtain fat for fat transfer (for such purposes as augmentation, correction of scar defects, etc.), and for weight loss.
- ASA Physical Status Classification System rating of P3 to P5.
- Use of narcotics, opiates, steroids and/or NSAIDs within one week prior to surgery.
- Any prior surgery to any of the area(s) to receive liposuction.
- Active infection or wound in any part of the body, including the intended areas of treatment.
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(R) LipoLASER PL; Erchonia(R) EML LaserThe Erchonia(R) EML Laser is a low level laser light therapy medical device that was applied during the liposuction procedure, by emitting 1 mw of red (635nm wavelength) light via a Class II electric laser diode energy source (CDRH classification). The fluence is considered to be at 10.8 joules per area treated. | Device | Erchonia (R) LipoLASER PL |
| Erchonia(R) LipoLASER PL | Device | placebo laser |
Primary outcome
Subject self-reported Degree of Pain rating on the standardized 0-100 Visual Analogue Scale (VAS) at 24 hours post-surgery.
Time frame: 24 hours
6 secondary outcomes
Ease of the process of fat extraction during the liposuction procedure
Time frame: immediately post surgery
Emulsification (consistency) of extracted fat
Time frame: immediately post surgery
Amount of time spent by volume of fat removed
Time frame: Immediately post surgery
Degree of swelling at the surgical site
Time frame: 7 days post surgery
Subject self-reported degree of post-surgical pain
Time frame: 7, 14 and 28 days post surgery
Use of recovery pain medication
Time frame: Through the 1st 7 post-surgical days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2009.
- FDA 510(k) clearance listing resulting from the outcome of this clinical studyLink provided by the sponsor.
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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.
Robert F Jackson, MD, FACS principal investigator
Gregory Roche, DO principal investigator
Kimberly Butterwick, MD principal investigator
Questions about this trial
What is this clinical trial studying?
A study testing Erchonia(R) LipoLASER PL; Erchonia(R) EML Laser and Erchonia(R) LipoLASER PL in people with Pain, run by Erchonia Corporation.
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 13 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 26 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Subject self-reported Degree of Pain rating on the standardized 0-100 Visual Analogue Scale (VAS) at 24 hours post-surgery. (time frame: 24 hours). 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 26 Jun 2009.