Gastrointestinal motility disorders remain significant both in terms of patient symptom prevalence and health care resource use. In diagnosing many such disorders, manometry remains the gold standard because of its sensitivity to motor dysfunction. High-resolution pressure imaging has been shown to provide improved and more reliable diagnoses over conventional methods. Current clinical manometry systems are limited due to their low number of achievable sensors (solid state strain gauge technology) or difficulty of use (water perfused equipment). In Phase I we successfully demonstrated the world's first high-resolution solid-state manometric catheter. The production and test of this prototype with supporting electronics and software exceeded all initially proposed accomplishments of that phase. In Phase 11, we will develop this Motility Visualization System (MVS) into a commercial-ready form, validate it through clinical trials, and obtain FDA approval. The MVS has unique benefits for physicians, clinical technical staff, and patients. The large number of sensors distributed over a relatively long length of the catheter will simplify and shorten the clinical procedure and yield consistent site-to-site motility study results. The graphical visualization software supports rapid and reliable diagnoses. This technology has the power to revolutionize clinical motility practices.
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