The SmartPill Corporation today announced that 510(k) clinical trials of its SmartPill ACT-I Capsule and GI Monitoring System are expected to begin on or about May 6th at the University at Buffalo (UB) School of Medicine and Biomedical Sciences (Buffalo, NY), bringing to four the number of sites participating in the SmartPill 510(k) clinical trial.
Buffalo, NY (PRWEB) April 26, 2005 -- The SmartPill Corporation (smartpillcorp.com), developer of the SmartPill Capsule, a non-invasive, ingestible medical device that captures biomedical data from within a patients GI tract, today announced that 510(k) clinical trials of its SmartPill ACT-I Capsule and GI Monitoring System are expected to begin on or about May 6th at the University at Buffalo (UB) School of Medicine and Biomedical Sciences (Buffalo, NY), bringing to four 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. Professor of Medicine Michael D. Sitrin, M.D., who heads the UB Department of Gastroenterology, will conduct the study as the principal investigator, and will receive support from Assistant Professor of Medicine Jeffrey M. Lackner, Psy.D. 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, The University at Buffalo was the genesis of SmartPill Capsule technology, and supported Phase I physiological trials of the SmartPill ACT-I Capsule in 2004. The University at Buffalo has been and will continue to be a very important strategic clinical partner to us as we approach eventual 510(k) approval and market launch."
The UB School of Medicine and Biomedical Sciences trial is expected to run 8 – 10 weeks, paralleling clinical trials now underway at Massachusetts General Hospital (Boston, MA), Temple University Hospital (Philadelphia, PA), and Wake Forest (Winston-Salem, NC). Additional clinical trial sites will be announced in the coming weeks, pending IRB approvals.
About University at Buffalo School of Medicine and Biomedical Sciences
The University at Buffalo is a premier research-intensive public university, the largest and most comprehensive campus in the State University of New York. UBs more than 27,000 students pursue their academic interests through more than 300 undergraduate, graduate and professional degree programs. The university offers the only degrees in law, pharmacy and architecture in the SUNY system, and is the home of the only comprehensive public school of engineering in New York State. The School of Medicine and Biomedical Sciences is one of 12 professional schools at the University at Buffalo. Learn more at www.smbs.buffalo.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 www.smartpillcorp.com or call The SmartPill Corporation at 800.644.4162.
# # #
|
