SmartPill said that the Food and Drug Administration 510(k) clinical trials of its ACT-I capsule and gastrointestinal monitoring system are expected to begin on or about May 6 at the University at Buffalo School of Medicine and Biomedical Sciences in Buffalo, NY.
Twenty-five subjects, including 15 who are healthy and 10 who have been documented with gastroparesis, are expected to participate in the study, the company said. The primary objective is to demonstrate the correlation between the gastric residence times measured by the SmartPill ACT-I Capsule and by the ingestion of a radiolabeled meal and scintigraphic images, according to the Buffalo, NY-based firm.
The Buffalo facility is the fourth site participating in the 510(k) clinical trial, SmartPill said.
By AuntMinnie.com staff writers
April 26, 2005
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