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 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 trial 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 health care 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 asset, 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

b)       To view NIH clinical trial records, click here 

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)       Study results used as SE submission K050672

c)       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--  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)       Carpal Tunnel Syndrome/Low Level Laser- 2004 -- Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study

a)       IRB Approved

b)       Awaiting implementation

5)       Breast Implantation/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)       Hair Restoration/Low Level Laser – 2008 -- Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study

a)       IRB Approved

b)       Awaiting implementation

7)       Burn Healing and Pain Reduction/Low Level Laser – 2005--Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study

a)       In development

b)       FDA final evaluation in process done waiting on grant money.

8)       Low Back Pain – 2008 - Sponsor and Monitor, double blind, placebo controlled, multi-site, clinical study

a)       Developing the study protocol

9)       Body Contouring –Laser Scanner Waist Hip and Thighs-Pilot Study

a)       Study results used to obtain FDA clearance – K041139

b)       To view NIH clinical trial records, click here

10)       Capsular Structure Study – James Baker, MD – 2008

a)       Study Protocol Submitted for Review

b)       Awaiting IRB Approval

11)   Tinnitus/Low Level Laser – Sponsor and Monitor, IRB Approved, Double-Blind, Placebo Controlled, Multi-Site, Clinical Study

a)       Study terminated, new information provided to develop a new protocol

b)       To view NIH clinical trial records, click here

12)   Word Recognition/Low Level Laser – Sponsor and Monitor, IRB Approved, Double-Blind, Placebo Controlled, Multi-Site, Clinical Study

a)       Study Results included in 510(k) submission

b)       To view NIH clinical trial records, click here

13)   Cellulite Clinical Trial – Sponsor and Monitor, IRB Approved, Double-Blind, Placebo Controlled, Multi-Site, Clinical Study

a)       Obtained IRB Approval

b)       Study submitted to FDA

c)     Study Ongoing

14)   Reduction of Triglycerides and Cholesterol – Sponsor and Monitor, IRB Approved, Double-Blind, Placebo Controlled, Multi-Site, Clinical Study

a)       Obtained IRB Approval

b)       Study Ongoing 

15)   Toe Nail Fungus – Sponsor and Monitor, IRB Approved, Double-Blind, Placebo Controlled, Multi-Site, Clinical Study

a)       Study submitted to FDA and waiting on Comments

b)       Study scheduled to start 6/2010

16)   Parkinson's Clinical Trial – Sponsor and Monitor, IRB Approved, Double-Blind, Placebo Controlled, Multi-Site, Clinical Study

a)       Study submitted to FDA and waiting on Comments

       b)       Study scheduled to start 6/2010

17)   Venous Stasis Ulcers Clinical Trial – Sponsor and Monitor, IRB Approved, Double-Blind, Placebo Controlled, Multi-Site, Clinical Study

a)       Study submitted to FDA and waiting on Comments

        b)       Study scheduled to start Fall 2010

18)   Sistic Acne – Sponsor and Monitor, IRB Approved, Double-Blind, Placebo Controlled, Multi-Site, Clinical Study

a)       Study started 02/2010