SmartPill begins clinical trials

SmartPill of Buffalo, NY, has reported that 510(k) clinical trials of its SmartPill capsule, a noninvasive ingestible medical device that captures biomedical data from within a patient's GI tract, are set to begin next week at Wake Forest University Baptist Medical Center in Winston-Salem, NC.

A total of 25 subjects, 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 firm.

The Wake Forest trial is expected to run eight to 10 weeks, paralleling clinical trials now under way at Massachusetts General Hospital in Boston, and at Temple University Hospital in Philadelphia, SmartPill said.

By staff writers
April 12, 2005

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