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| Sponsor: | Erchonia Corporation |
|---|---|
| Information provided by: | Erchonia Corporation |
| ClinicalTrials.gov Identifier: | NCT00927277 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Pain |
Device: Erchonia(R) LipoLASER PL; Erchonia(R) EML Laser Device: Erchonia(R) LipoLASER PL |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Erchonia Medical, Inc., Erchonia EML Laser Liposuction Clinical Study V Protocol |
| Enrollment: | 70 |
| Study Start Date: | March 2003 |
| Study Completion Date: | March 2004 |
| Primary Completion Date: | March 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: placebo laser
inactive light on the laser device.
|
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.
|
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.
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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.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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:
INCLUSION CRITERIA FOR THE CLINICAL STUDY
EXCLUSION CRITERIA
Contacts and Locations
More Information
| Responsible Party: | Mr. Steven Shanks, President, Erchonia Medical, Inc. |
| ClinicalTrials.gov Identifier: | NCT00927277 History of Changes |
| Other Study ID Numbers: | ELIPO-001 |
| Study First Received: | June 22, 2009 |
| Last Updated: | June 25, 2009 |
| Health Authority: | United States: Institutional Review Board |