Gastroparesis Clinical Trial
Official title:
Comparison of the Atmo Motility Gas Capsule System to the Reference Standard (SmartPill) for Gastrointestinal Transit Time Measures in Patients With Functional Gastrointestinal Symptoms and Dysmotility
The study objective is to demonstrate the equivalence of the Atmo Motility Gas Capsule System with the predicate SmartPill in measuring gastric emptying time and colonic transit time through examination of device agreement.
The clinical protocol for the study is designed to compare the performance of the Atmo Motility Gas Capsule System to the predicate device, the SmartPill GI Monitoring System, in patients with chronic GI symptoms suggestive of GI motility disorders (specifically gastroparesis and slow transit constipation), in order to demonstrate substantial equivalence. This study will involve the recruitment of symptomatic participants from a population that is representative of that for which the device is intended. The primary objective of this study is the assessment of the agreement of Atmo Motility and SmartPill Systems' results with regards to both GET and CTT. The SmartPill is the accepted gold standard test for GI motility transit time analysis. Device agreement will be primarily examined through Bland-Altman analyses for GET and CTT measurements from the Atmo Motility and SmartPill Systems. ;
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