Low Level Laser Light Therapy as an Aid to Liposuction

NCT00927277 | Completed

• 1 other identifier: ELIPO-001
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Subject self-reported Degree of Pain rating on the standardized 0-100 Visual Analogue Scale (VAS) at 24 hours post-surgery.

  24 hours

Secondary Outcomes (6)

• Ease of the process of fat extraction during the liposuction procedure

  immediately post surgery

• Emulsification (consistency) of extracted fat

  immediately post surgery

• Amount of time spent by volume of fat removed

  Immediately post surgery

• Degree of swelling at the surgical site

  7 days post surgery

• Subject self-reported degree of post-surgical pain

  7, 14 and 28 days post surgery

Study Arms (2)

placebo laser

PLACEBO COMPARATOR

inactive light on the laser device.

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.

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

Interventions

Erchonia(R) LipoLASER PL; Erchonia(R) EML Laser DEVICE

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 PL

Erchonia(R) LipoLASER PL DEVICE

placebo laser

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.
• to 55 years, inclusive.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erchonia Corporation: lead

Related Links

• FDA 510(k) clearance listing resulting from the outcome of this clinical study

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert F Jackson, MD, FACS

  PRINCIPAL INVESTIGATOR

• Gregory Roche, DO

  PRINCIPAL INVESTIGATOR

• Kimberly Butterwick, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 22, 2009
• First Posted: June 24, 2009
• Study Start: March 1, 2003
• Primary Completion: March 1, 2004
• Study Completion: March 1, 2004
• Last Updated: June 26, 2009

Record last verified: 2009-06