Clinical Research

Clinical research, is the generic name given to the branch of medical science that determines the safety and effectiveness of medications, devices, diagnostic products, and treatment regimens intended for human use.  The term refers to the entire biography of its focus, whether a method, application, and/or device, covering the process through the concept, feasibility, and viability phases.  Clinical research is conducted with a specific goal in mind, for Erchonia Corporation it is the advancement of low-level laser healthcare.   

Research sponsored by Erchonia, begins with a concept, identified as an area low-level laser application that can have a benefit.  The management of Erchonia Corporation and a benchmark group of physicians, in the field of practice associated with the area, define the scope of a study.  The pilot study is launched and worked with the benchmark group of physician(s).  Results reached specific milestones are assessed and feasibility is determined.  Once deemed feasible, a formal clinical trial protocol is developed.  Erchonia works through an Investigational Review Board to ensure the protocol is acceptable to the FDA.

Clinical trials depending on their scope can take years to conduct.  Erchonia Corporation makes this investment, as clinical trials are the foundational component of 510(k) submissions.  Not all clinical trials result in market clearance by the FDA and not all FDA clearance is dependent on the submitter’s clinical data; however; Erchonia is committed to advance Laser Healthcare™ through sponsored clinical trials as doing so ensures the protocols are developed by Erchonia, making Erchonia and the physicians working on our behalf, the most knowledgeable to teach the protocol and making protocols themselves and intellectual assets, patentable.

The following list of shows the clinical trials and an outline of their progress.  As a company, to protect our intellectual assets, not all clinical trials we are involved with are made public to ensure our competitive advantage, as such not all clinical trials are listed.

1)    Chronic Neck and Shoulder Pain/Low Level Laser--2000--Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study

        a)       First study done in support of 510(k) submission, second study requested 
         by FDA

2)       Chronic Neck and Shoulder Pain/Low Level Laser – 2001 -- Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study

a)       Study results used to obtain FDA clearance – K012580

b)       To view NIH clinical trial records, click here

3)    Low Level Laser Light Therapy as an Aid to Liposuction and Reduction of
        Pain Associated With Surgery--2004- - 
Sponsor and Monitor, IRB approved, 
        double blind, placebo controlled, multi-site, clinical study

        a)    Study results used to obtain FDA clearance – K041139

        b)    To view NIH clinical trial records, click here

4)    Acne Vulgaris-Dermatological Conditions/Low Level Laser--2005--Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study

         a)    FDA clearance – K050672

5)       Pain Associated with Breast Augmentation Surgery/Low Level Laser – 2007 -- Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study

  a)       Results used to obtain FDA clearance – K072206

  b)       To view NIH clinical trial records, click here 

6)      Non-Invasive Fat Reduction and Body Contouring –Laser Scanner Waist,  
         Hips, and Thighs--2009
--Sponsor and Monitor, IRB approved, double blind, 
         placebo controlled, multi-site, clinical study

 
           a)       Study results used to obtain FDA clearance – K082609
 
           b)       To view NIH clinical trial records, click here  

 
7)       Equine Wound Healing - 2011-- Sponsor, Case Study
 
           a)       Study completed from Nov. 2010-March 2011
 
           b)       Monitored by Hank Jann, DVM, MS, DACVS from Oklahoma State 
            University
 
8)       Equine Wound Healing - 2011 -- Sponsor, placebo controlled, clinical study
 
            a)       Study completed from Feb. 2011-April 2011
 
            b)       Monitored by Hank Jann, DVM, MS, DAVCS from Oklahoma State
            University
 
 
9)    Arm Circumference Reduction of the Upper Arms -- 2011 -- Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study

    a)    Study results used to obtain FDA clearance – K120257
 
          b)    Study submitted to be published 2012
 
    c)    To view NIH clinical trial records, click here 
 
10)    Appearance of Cellulite -- 2012 -- Sponsor and Monitor, IRB approved, double blind, placebo controlled,
 multi-site, clinical study

    a)    FDA clearance - K130922
 
          b)    Study submitted to be published 2013.
 
  c)    To view NIH clinical trial records, click here 

 

11)    Non-Invasive Body Contouring Using GLS Laser - 532 nm (Green) Trade Name Verju -- 2012 -- Sponsor and Monitor, IRB approved, double blind, placebo controlled,
 multi-site, clinical study

    a)    FDA clearance - K123237
 
          b)    Study submitted to be published 2013.
 
    c)    To view NIH clinical trial records, click here
 
12)    Adjunct to Chronic Heal Pain Arising from Plantar Fasciitis Using the Erchonia Allay Laser-- 2012 -- Sponsor and Monitor, IRB approved, double blind, placebo controlled,  multi-site, clinical study

    a)    FDA clearance - K132940
 
          b)    Study results published in the American Orthopaedic Foot & Ankle Society April 2014
 
          c)    To view NIH clinical trial records, click here