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A Study to See if Low Level Laser Light Therapy (LLLT) Can Improve the Condition of Nonalcoholic Steatohepatitis (NASH)

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ClinicalTrials.gov Identifier: NCT03163810
Recruitment Status : Terminated (Difficulty with recruitment)
First Posted : May 23, 2017
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Erchonia Corporation

Brief Summary:
The purpose of this study is to determine whether low level laser therapy (LLLT) using the Erchonia VERJU and EVRL laser devices is effective in reducing aminoalanine transaminase (ALT) levels in individuals with nonalcoholic steatohepatitis (NASH).

Condition or disease Intervention/treatment Phase
Nonalcoholic Steatohepatitis Device: Erchonia Verju Laser Device: Erchonia EVRL Laser Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Evaluation of the Effect of the Erchonia Verjú™ and EVRL Lasers on Reducing Aminoalanine Transaminase (ALT) in Individuals With Nonalcoholic Steatohepatitis (NASH)
Actual Study Start Date : February 6, 2017
Actual Primary Completion Date : December 13, 2017
Actual Study Completion Date : December 13, 2017


Arm Intervention/treatment
Experimental: Erchonia Verju and EVRL Laser

The Erchonia Verju Laser has 6 diodes that each emit 17 milliwatts (mW) 532 nanometers (nm) of green laser light.

The Erchonia EVRL Laser emits 635 nanometers (nm) red light and 405 nm blue light simultaneously

Device: Erchonia Verju Laser
The Erchonia Verju Laser is applied 2 times a week to the front and back of the waist, hips and upper abdomen for 30 minutes each time over 8 to 12 weeks.

Device: Erchonia EVRL Laser
The Erchonia EVRL Laser is applied under the right ribcage angled towards the liver for 10 minutes, one time per week over the same 8 to 12 weeks as the Verju Laser is administered.




Primary Outcome Measures :
  1. Percent (%) change from Baseline to Subject Study Endpoint evaluation in aminoalanine transaminase (ALT) level. [ Time Frame: 2 or 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Review of subject's pre-existing medical records to confirm the current diagnosis of nonalcoholic steatohepatitis (NASH) according to the following criteria:

    • ALT elevated on two separate determinations
    • Abdominal ultrasound showing fatty liver
    • Blood work that excludes other potential etiologies of liver disease
  • Subject has been on a stable diet and exercise regimen for NASH within the prior 6 months
  • Subject agrees to maintain his or her current diet and exercise regimen throughout study participation
  • Subject agrees to abstain from participating in any new treatments for NASH, other than the study treatments, throughout the course of study participation
  • Elevated aminoalanine transaminase (ALT) level, defined as 20 or more Unites/Liter (U/L) above the normal gender-specific ALT levels: males: ALT ≥ 60 U/L; females: ALT ≥ 50 U/L

Exclusion Criteria:

  • History of cardiovascular disease or events including, but not limited to, coronary artery disease, valvular heart disease, cardiac arrhythmias, congestive heart failure, myocardial infarction, stroke, transient ischemic attack, or peripheral vascular disease
  • Cardiac surgeries or procedures, including but not limited to, coronary artery bypass surgery or stent placement, heart transplantation, pacemaker insertion or implantation of a defibrillator
  • An implanted device in the target area to receive low level laser light therapy (e.g. pain pump, lap band, penile inflation device, ventriculo-peritoneal shunts, etc.)
  • Known photosensitivity disorder
  • Current active cancer or within one year of cancer treatment or remission
  • Excessive alcohol consumption defined as 14 or more alcoholic drinks per week
  • Pregnant, breastfeeding, or planning pregnancy prior to the end of study participation
  • Serious mental health illness that in the opinion of the investigator would preclude the subject from study participation
  • Active infection, wound or other external trauma to the target area to receive the laser therapy
  • Developmental disability or cognitive impairment that in the opinion of the investigator would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements
  • Involvement in litigation and/or a worker's compensation claim and/or receiving disability benefits related to NASH
  • Participation in a clinical study or other type of research in the past 30 days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03163810


Locations
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United States, Arizona
Meridian Integrative Medicine
Scottsdale, Arizona, United States, 85250
Sponsors and Collaborators
Erchonia Corporation
Investigators
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Principal Investigator: Charles M Schron, MD

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Responsible Party: Erchonia Corporation
ClinicalTrials.gov Identifier: NCT03163810     History of Changes
Other Study ID Numbers: EC_NASH_PILOT
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases