Low Level Laser Light Therapy as an Aid to Liposuction

• ClinicalTrials.gov Identifier: NCT00927277
• Recruitment Status: Completed
• First Posted: June 24, 2009
• Last Update Posted: June 26, 2009
• Sponsor: Erchonia Corporation
• Information provided by: Erchonia Corporation

Tracking Information

• First Submitted Date: June 22, 2009
• First Posted Date: June 24, 2009
• Last Update Posted Date: June 26, 2009
• Study Start Date: March 2003
• Actual Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 23, 2009): 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 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 23, 2009)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Low Level Laser Light Therapy as an Aid to Liposuction
• Official Title: Erchonia Medical, Inc., Erchonia EML Laser Liposuction Clinical Study V Protocol
• Brief 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.
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Pain

Intervention

• Device: Erchonia(R) LipoLASER PL; Erchonia(R) EML Laser
  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.
• Device: Erchonia(R) LipoLASER PL

Study Arms

• Placebo Comparator: placebo laser
  inactive light on the laser device.
  Intervention: Device: Erchonia(R) LipoLASER PL
• Active Comparator: Erchonia (R) LipoLASER PL
  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.
  Intervention: Device: Erchonia(R) LipoLASER PL; Erchonia(R) EML Laser

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 23, 2009): 70
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: March 2004
• Actual Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria: There were separate inclusion criteria for both the liposuction and the clinical study components of the study.

INCLUSION CRITERIA FOR THE LIPOSUCTION PROCEDURE

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.

INCLUSION CRITERIA FOR THE CLINICAL STUDY

• Signed clinical study informed consent form.
• Liposuction procedure intended for the removal of localized deposits of adipose tissue for the purpose of body contouring.
• 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.

EXCLUSION CRITERIA

• 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.
• 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00927277
• Other Study ID Numbers: ELIPO-001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Mr. Steven Shanks, President, Erchonia Medical, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Erchonia Corporation
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Robert F Jackson, MD, FACS
• Principal Investigator: Gregory Roche, DO
• Principal Investigator: Kimberly Butterwick, MD

• PRS Account: Erchonia Corporation
• Verification Date: June 2009