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Ensaio clínico

Mapeamento da Superfície Corporal Gástrica para Avaliação de Pacientes com Sintomas Gastrointestinais Superiores e Controles

NCT: NCT05812339 · ENROLLING_BY_INVITATION

ID NCTNCT05812339
EstadoENROLLING_BY_INVITATION
Data de início2022-11-01

Resumo breve

This is an analytical validation observational cohort study is designed to provide evidence of: safety and reliability of Body Surface Gastric Mapping using the Gastric Alimetry System (GAS), normal reference values, and correlation of metrics with patient symptoms among healthy adults and patients diagnosed with upper abdominal motility disorders. GAS is intended to record, store, view and process gastric myoelectrical activity. This is a proprietary system consisting of multiple electrodes arranged on an array that is placed precisely over the stomach, a reader to collect the electrode measurements and a smart tablet application to track patient reported symptoms. Participants meeting inclusion and exclusion criteria will continue fasting for 30 minutes after the Gastric Alimetry System has been applied and begun measuring, eat a standard study meal within 10 minutes and remain quietly seated, reclining, for 4 hours as the GAS continues to collect data. The array is removed and the abdomen is examined for evidence of skin effects.

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