Clinical Testing Of The SmartPill Capsule Is Set To Begin At Wake Forest University Baptist Medical Center
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 of a radio-labeled meal and scintigraphic images.
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."
The Wake Forest trial is expected to run 8 - 10 weeks, paralleling clinical trials now underway at Massachusetts General Hospital (Boston, MA) and Temple University Hospital (Philadelphia, PA). Additional clinical trial sites will be announced in the coming weeks, pending IRB approvals.