Clinical Testing of the SmartPill Capsule is Set to Begin at Wake Forest University Baptist Medical Center; Wake Forest is a Leading GI Motility Research Center and the Third Clinical Trial Site to Come Online.BUFFALO, N.Y. -- The SmartPill Corporation (smartpillcorp.com), developer of the SmartPill Capsule, a non-invasive, ingestible medical device that captures biomedical data from within a patient's GI tract, today announced that 510(k) clinical trials of its SmartPill ACT-I Capsule and GI Monitoring System are set to begin at Wake Forest University Baptist Medical Center This article or section needs sources or references that appear in reliable, third-party publications. Alone, primary sources and sources affiliated with the subject of this article are not sufficient for an accurate encyclopedia article. (Winston-Salem, NC) the week of April 18th, bringing to three the number of sites participating in the SmartPill 510(k) clinical trial. A total of 25 subjects, 15 who are healthy and 10 who have been documented with gastroparesis, the inability of the stomach to empty, are expected to participate in the study. Kenneth Koch, M.D., who heads the Section on Gastroenterology at Wake Forest University Baptist Medical Center, will conduct the study as the principal investigator. The primary objective of the study is to demonstrate the correlation between the gastric residence times measured by the SmartPill ACT-I Capsule and by the ingestion ingestion /in·ges·tion/ (-chun) the taking of food, drugs, etc., into the body by mouth. in·ges·tion n. 1. The act of taking food and drink into the body by the mouth. 2. of a radio-labeled meal and scintigraphic images. David Barthel, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of The SmartPill Corporation, said, "Wake Forest is one of the preeminent institutions engaged in gastroenterology-related research and therapy development. We are extremely pleased with the level of commitment we have received from Dr. Koch and the WFU WFU Wake Forest University WFU Wildland Fire Use Baptist Medical Center IRB IRB See: Industrial Revenue Bond , and look forward to the results of their study." Kenneth Koch, M.D., said, "The SmartPill Capsule is one of the most exciting new GI motility motility /mo·til·i·ty/ (mo-til´ite) the ability to move spontaneously.mo´tile Motility Motility is spontaneous movement. technologies I have seen emerge in the last ten years. Its tubeless, capsule technology holds the promise of providing conclusive indications of gastroparesis and a host of other motility disorders that historically have been very difficult to accurately diagnose." The Wake Forest trial is expected to run 8 - 10 weeks, paralleling clinical trials now underway at Massachusetts General Hospital Massachusetts General Hospital Health care The major teaching hospital for Harvard Medical School, widely regarded as one of the best health care centers in the world (Boston, MA) and Temple University Hospital (Philadelphia, PA). Additional clinical trial sites will be announced in the coming weeks, pending IRB approvals. About Wake Forest University Baptist Medical Center Wake Forest Baptist is an academic health system comprised of North Carolina Baptist Hospital and Wake Forest University Health Sciences, which operates the university's School of Medicine. The system comprises 1,282 acute care, psychiatric, rehabilitation and long-term care beds and is consistently ranked as one of "America's Best Hospitals America's Best Hospitals Media & health An annual 'report card' on the quality of care received in US hospitals published by US News & World Report, that is either proudly quoted by those who are rated or dismissed by those who are not " by U.S. News & World Report U.S. News & World Report Weekly newsmagazine published in Washington, D.C. U.S. News was founded in 1933 by David Lawrence (1888–1973) to cover important domestic events; he founded World Report in 1945 to treat world news. The two magazines were merged in 1948. . Learn more at www.wfubmc.edu. About The SmartPill Corporation The SmartPill Corporation is the leading developer of SmartPill capsule technology that non-invasively aids in the definition, diagnosis, and therapeutic intervention of GI motility disorders; presents a more comfortable and convenient alternative to invasive GI diagnostic procedures; and reduces the cost of exploratory GI examinations. The SmartPill ACT-I Capsule and GI Monitoring System capture and present biomedical parameters that can be expected to assist Gastroenterologists and researchers in the accurate diagnosis of GI motility disorders, and lead to more effective and lower-cost therapies. Learn more at smartpillcorp.com or call The SmartPill Corporation at 800.644.4162. |
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