Avacen Medical announced its strong support for a new initiative by the National Institutes of Health (NIH) to expand and enforce its requirement for clinical trial results to be published on ClinicalTrials.gov.
The goal of stricter enforcement is to make data from trials more widely available to the public. Avacen’s own fibromyalgia clinical trial information can be found on ClinicalTrials.gov (NCT01619579).
In a press release, Avacen cites a posting on the U.S. Department of Health & Human Services website quoting NIH Director Dr. Francis S. Collins, MD, PhD, who wrote: “Access to more information about clinical trials is good for patients, the public and science. The final rule and NIH policy we have issued today will help maximize the value of clinical trials, whether publicly or privately supported, and help us honor our commitments to trial participants, who do so much to help society advance knowledge and improve health.”
According to Avacen Medical CEO Thomas Muehlbauer said he’s been disappointed for a long time that most prestigious research institutions “have blatantly violated a federal law requiring public reporting of clinical study results.”
“Not reporting study results can deny patients and doctors access to important data to help evaluate the safety and potential benefits of new treatments,” Muehlbauer said. “After completing our fibromyalgia study, I found that posting the trial results on ClinicalTrials.gov to be a time consuming and arduous process. And, if our results were not so encouraging, I most likely would have considered avoiding the reporting process. Hopefully this process can be simplified to increase reporting compliance.”
The objective of the Phase 2 Avacen clinical trial, “Investigation of AVACEN Thermal Exchange System for Fibromyalgia Pain,” completed in 2013 and updated in November 2015, was to evaluate whether daily use of the Avacen Thermal Exchange System for four weeks would improve fibromyalgia pain and functioning markers.
Veterans’ Affairs San Diego and the University of California, San Diego, collaborated in the trial with Avacen. The trial showed statistically significant reductions in widespread pain and mean arterial pressure in study participants using the Avacen system.
How extensive is non-reporting of clinical trials?
The Avacen release cites an investigation conducted by the health and medical reporting website Statnews.com that found that the worst non-reporting offenders included four top 10 federal medical research funding recipients from the NIH. The website maintains that that these violations leave “gaping holes” in the federal database that is referenced by millions of patients, families, and medical professionals, frequently for the purpose of comparing effectiveness and side effects of treatments for serious diseases.
Over the past two years, Avacen Medical has been awarded three U.S. and eight international patents for its proprietary apparatus and methods supporting its medical pain therapy technique called The Avacen Treatment Method (ATM).
With over 3,000 programmed microprocessor instructions, the Avacen 100 device is designed to provide and regulate noninvasive and safe continuous infusion of heat into the circulatory system, which it does by way of an arrangement of blood vessels in the palm of the hand called the arteriovenous anastomosis (AVAs), which act as a radiator to dump the body’s excess heat.
Avacen explains that its ATM process manipulates the AVAs so they can serve as a portal for infusing heat into the circulatory system. Dilated and distended by ATM, blood flow through an AVA can be up to 1,000 times more than smaller capillary volume.
Developed to support ATM, the Avacen 100 is an FDA-approved class 2 over-the-counter medical device. It claims to be the world’s only noninvasive medical device that allows self-treatment of patients from a single convenient treatment point (their palm) in the privacy of their own home. Avacen says it’s a cost-effective, simple drug-free alternative for muscle relaxation to reduce pain which can be associated with a range of medical conditions.
When the patient’s hand, enclosed in a patented mitt, is placed inside the Avacen device’s vacuum chamber, a microprocessor manages and regulates application of negative pressure and heat to safely increase the temperature and volume of blood flowing through the high volume AVAs. Avacen notes that applying heat without negative pressure will not be effective.
Avacen 100 users put their hand inside the device’s vacuum chamber and rest it on a pad heated to about 108 degrees Fahrenheit for 10 to 30 minutes. The company maintains that infusion of heat into the circulatory system reduces blood thickness (viscosity) and consequently increases microvascular circulation, which in turn enhances oxygen and nutrition delivery to the skeletal muscles while carrying away toxins.
The device is FDA-cleared as a heat therapy system for temporary relief of minor muscle and joint pain and stiffness; temporary relief of joint pain associated with arthritis; muscle spasms; minor strains and sprains; muscular relaxation; and the temporary increase of local circulation where applied.