Wake Forest Baptist Medical Center becomes the third 510(k) clinical trial site for the SmartPill Capsule, a non-invasive, ingestible medical device that captures biomedical data from within a patient’s GI tract.
The SmartPill Corporation announced the trials will begin next week with 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.
David Barthel, president and CEO 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 Baptist Medical Center IRB, 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 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.”