Principals
Robert
A. Casper, Ph.D
David
L. Gardner, Ph.D
Gastrointestinal
Devices
InteliSite Articles Clinical
Trials/StudiesRespiratory Devices
Services ArticlesPhone (919) 781-6315
email
devices@mindspring.com
InteliSite® Capsule Studies Performed in Human Volunteers
The first study with the InteliSite® capsule to determine drug absorption in different regions of the GI tract was performed in human volunteers in August, 1996. InteliSite® capsule studies now have been conducted in human volunteers at the following sites possessing capabilities in gamma camera scintigraphy for tracking of the InteliSite® capsule in the GI tract:
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Scintipharma, Inc. |
Scintiprox, Inc. |
In addition to tracking the InteliSite® capsule via gamma scintigraphy, a pharmaceutical company in Europe has conducted a study with the InteliSite® capsule using digital fluoroscopy to track the capsule. The results indicated the capsule can be successfully tracked in the GI tract without undue radiation exposure. Thus, both gamma scintigraphy and digital fluoroscopy may be used to track the capsule and to investigate regional drug absorption/bioavailability in the GI tract.
Institutional Review Boards (IRBs) at each of these study sites have judged the InteliSite® capsule to be a non-significant risk device when evaluating the clinical protocol and informational packet on the InteliSite® capsule prior to initiation of the study.