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

NCT03163810 | Withdrawn FDA Device

• 1 other identifier: EC_NASH_PILOT
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Nonalcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

• Percent (%) change from Baseline to Subject Study Endpoint evaluation in aminoalanine transaminase (ALT) level.

  2 or 3 months

Study Arms (1)

Erchonia Verju and EVRL Laser

EXPERIMENTAL

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; Device: Erchonia EVRL Laser

Interventions

Erchonia Verju Laser DEVICE

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.

Erchonia Verju and EVRL Laser

Erchonia EVRL Laser DEVICE

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.

Erchonia Verju and EVRL Laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Erchonia Corporation: lead

Study Sites (1)

Meridian Integrative Medicine

Scottsdale, Arizona, 85250, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Charles M Schron, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: May 23, 2017
• Study Start: February 6, 2017
• Primary Completion: December 13, 2017
• Study Completion: December 13, 2017
• Last Updated: January 28, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)