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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

  1. 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

  1. a)Study results used to obtain FDA clearance – K012580
  2. 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

  1. a) Study results used to obtain FDA clearance –K041139
  2. 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

  1. 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

  1. a) Results used to obtain FDA clearance – K072206
  2. 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

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

7) Equine Wound Healing – 2011— Sponsor, Case Study

  1. a) Study completed from Nov. 2010-March 2011
  1. b) Monitored by Hank Jann, DVM, MS, DACVS from Oklahoma State University

 

8) Equine Wound Healing – 2011 — Sponsor, placebo controlled, clinical study

  1. a) Study completed from Feb. 2011-April 2011
  1. 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

  1. a) Study results used to obtain FDA clearance –K120257
  2. b) Study submitted to be published 2012
  3. c) To view NIH clinical trial records, click here.

10) Appearance of Cellulite (Verju Laser System) — 2012 — Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study

  1. a) FDA clearance –K130922
  1. b) Study submitted to be published 2013.
  2. 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

  1. a) FDA clearance –K123237
  1. b) Study submitted to be published 2013.
  2. c) To view NIH clinical trial records, click here.

 

12) Adjunct to Chronic Heel Pain Arising from Plantar Fasciitis Using the Erchonia FX635 Laser– 2012 — Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study

  1. a) FDA clearance –K132940
  1. b) Study results published in theAmerican Orthopaedic Foot & Ankle Society April 2014
  1. c) To view NIH clinical trial records, click here.

 

13) Non-Invasive Dermatological Aesthetic Treatment for Reduction of Circumference of Hips, Waist and Upper Abdomen When Applied to Individuals with a Body Mass Index (BMI) between 30 kg/m2 and 40 kg/m2–2013– Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study

  1. a) FDA clearance –K142042
  1. b) To view NIH clinical trial records, click here.

 

14) Non-Invasive Dermatological Aesthetic Treatment for the Reduction of Circumference of Hips, Waist and Thighs (Zerona-Z6 OTC)— 2012 — Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study

  1. a) FDA clearance –K143007
  1. b) To view NIH clinical trial records, click here.

 

15) Non-Invasive Dermatological Aesthetic Treatment for the Reduction of Circumference of Hips, Waist, Thighs and Upper Abdomen ~ 6 Week Treatment Protocol (Zerona-Z6)— 2014 — Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study

  1. a) FDA clearance –K150446
  1. b) To view NIH clinical trial records, click here.

 

16) Erchonia EVRL (EVRL)–2016

       a. while using the red diode, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin,

       b. and while using the violet diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.

  1. a) FDA clearance – K152196

 

17) Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.) (Lunula Laser )— 2016 — Sponsor and Monitor, IRB approved, blind, placebo controlled, clinical study

  1. a) FDA clearance –K153164
  1. b) To view NIH clinical trial records, click here.

 

18) Non-invasive dermatological aesthetic treatment for the reduction of body circumference. (Zerona-Z6)— 2016

  1. a) FDA clearance –K162578

 

19) Market Clearance to Treat Chronic Low Back Pain. (FX 635)— 2018 — Placebo-Controlled, Randomized, Double-Blind, Parallel-Group, Multi-Center clinical study

    1. a) FDA clearance –K180197
    1. b) To view NIH clinical trial records, click here.

 

20) Market Clearance for Relief of Chronic Musculoskeletal Pain (FX 635)— 2019 — A collection of Placebo-Controlled, Randomized, Double-Blind, Parallel-Group, Multi-Center clinical study

    1. a) FDA clearance –K190572

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