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

Withdrawn before enrolling · Not applicable

Conditions studied: Nonalcoholic Steatohepatitis

In brief

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).

Key facts

Study ID

NCT03163810

Run by

Erchonia Corporation

People needed

0

Starts

2017-02-06

Expected to finish

2017-12-13

Last updated by the study team

2020-01-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Meridian Integrative Medicine — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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