A novel scalable electrode array and system for non-invasively assessing gastric function using flexible electronics

Abstract

Abstract Disorders of gastric function are highly prevalent, but diagnosis often remains symptom-based and inconclusive. Body surface gastric mapping is an emerging diagnostic solution, but current approaches lack scalability and are cumbersome and clinically impractical. We present a novel scalable system for non-invasively mapping gastric electrophysiology in high-resolution (HR) at the body-surface. The system comprises a custom-designed flexible HR sensor array and portable data-logger synchronized to an App, with automated analysis and visualization algorithms. The novel system underwent performance testing then validation in 24 healthy subjects. In all subjects, gastric electrophysiology and meal responses were successfully captured and mapped non-invasively (mean frequency 2.9 ± 0.3 cycles per minute; peak amplitude at mean 60 m postprandially with return to baseline in <4 h). Spatiotemporal mapping showed regular and consistent wave activity of mean direction 182.7°±73 (74.7% antegrade, 7.8% retrograde, 17.5% indeterminate). The presented system is a new diagnostic tool for assessing gastric function that is scalable, validated, and ready for clinical applications, offering several biomarkers that are new to gastroenterology practice.