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Current Clinical Trials in Otolaryngology
The Department of Otolaryngology - Head and Neck Surgery at MUSC advances the research of pharmaceutical, biological and medical device products by developing collaborations between industry and academia. The department seeks to provide an efficient integration of academic expertise and industry clinical objectives. The Department offers its industry sponsors access to valuable scientific leadership in the areas of clinical trials, evidence-based health care, and analysis of high quality clinical trial data.
Dr. Shaun Nguyen, ENT physicians, and their staff provide the Charleston area and the state of South Carolina with groundbreaking medical treatment options through ongoing clinical research trials. New trials are added on a routine basis. Clinical trials give patients access to new research treatments before the treatments are widely available.
Highlighted Studies
Investigating a Novel Therapy with Intratympanic Injection in Meniere's Disease
Otonomy has developed a product, OTO-104, that is a suspension of dexamethasone in poloxamer. After IT injection, OTO-104, transitions from solution to gel state in the middle ear thereby increasing middle ear residence time which allows for sustained presence of dexamethasone at the round window membrane and in the inner ear fluids. MUSC is currently recruiting patients to participate in a randomized, double-blind, placebo-controlled trial of IT injections of OTO-104 (long-acting dexamethasone) in Meniere's disease. In this study, two different doses of OTO-104 will be assessed for safety, as well as to determine whether OTO-104 can provide Meniere's disease subjects with a clinically meaningful effect of enhanced vertigo control. A description of this trial can be found at the following link:
http://clinicaltrials.gov/ct2/show/NCT01412177?term=oto-104&rank=2
Effects of the Inspire Implantable Nerve Stimulation System on Obstructive Sleep Apnea
Inspire Upper Airway Stimulation (UAS) therapy is a dynamic, implantable therapy that works with the body's natural physiology to prevent airway obstruction during sleep. While the
OSA patient sleeps, Inspire therapy is designed to deliver physiologically timed, mild stimulation to the hypoglossal nerve on each breathing cycle. The stimulation is intended to restore tone to the muscles that control the base of the tongue, preventing the tongue from collapsing and obstructing the airway. Patients control when the therapy is turned on and off via a handheld programmer. In contrast to other surgical procedures to treat sleep apnea, Inspire therapy does not require removing or permanently altering an OSA patient's facial or airway anatomy.
The STAR trial is a global, multi-center clinical trial which will assess the safety and effectiveness of Inspire Upper Airway Stimulation (UAS) therapy in patients who suffer from moderate to severe obstructive sleep apnea (OSA). The trial will be conducted at leading medical centers throughout the United States and Europe. For more information on The STAR trial, visit
www.theSTARtrial.com
The Department of Otolaryngology presently has more than 30 clinical trials. If you are interested in any of these studies, please visit http://scresearch.org/
Shaun A. Nguyen, MD, CPI is the first physician to receive Certified Physician Investigator (CPI) status at MUSC. This is a Board Certification by the Academy of Pharmaceutical Physicians and Investigators (APPI). Major pharmaceutical companies and Clinical Research Offices (CRO's) now encourage CPI certification as it benefits the public, healthcare professionals and the healthcare industry by identifying standards for practice. There are currently 1,400 physicians with CPI certification in the United States. Dr. Nguyen has been involved in biomedical and clinical research since 2001 and has served as PI and Co-I on more than 70 clinical trials.
Shaun A. Nguyen, M.D., M.A., C.P.I.
Assistant Professor
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