Erchonia Medical, Inc., Erchonia EML Laser Liposuction Clinical Study V Protocol
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pain
- Sponsor
- Erchonia Corporation
- Enrollment
- 70
- Primary Endpoint
- Subject self-reported Degree of Pain rating on the standardized 0-100 Visual Analogue Scale (VAS) at 24 hours post-surgery.
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
Investigators
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).
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Amount of time spent by volume of fat removed(Immediately post surgery)
- Ease of the process of fat extraction during the liposuction procedure(immediately post surgery)
- Emulsification (consistency) of extracted fat(immediately post surgery)
- Subject self-reported degree of post-surgical pain(7, 14 and 28 days post surgery)
- Degree of swelling at the surgical site(7 days post surgery)
- Use of recovery pain medication(Through the 1st 7 post-surgical days)