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

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.

Gastric dysfunction in patients with chronic nausea and vomiting syndromes defined by a novel non-invasive gastric mapping device

“…1 . This system has been comprehensively validated to specifically detect gastric myoelectrical activity, 26,27 and also registers gastric contractile activity through an increase in signal power. 31 The standard Gastric Alimetry test protocol was followed ( Fig.…”

“…A) Outline of standardized BSGM test procedure. 27 B) The Gastric Alimetry Device, shown in closed and open profiles, during setup of the high-resolution array (8×8 pre-gelled Ag/AgCl electrodes), and in position overlying the epigastrium. C .…”

“…52 In this study, these variables were visualized for the entire test period, but calculated in statistical analyses based on the first 2 hr postprandially, when gastric activity is typically most active and SNR is highest. 27…”

“…Test quality was assessed by the consensus panel on a scale of 1 to 4, incorporating the following features according to the Gastric Alimetry labeling. a) successful stomach localization (>7 electrodes localized within mapped fields) 27 b) impedance (<200 kΩ optimal; <500 kΩ acceptable; 500+ kΩ poor) c) proportion of artifacts (<20% optimal; <50% acceptable; >50% interpret with caution) -Tests of score 1 were excluded, tests of score 2 were included but with caution advised in classification as normal or abnormal, and tests of 3-4 were included with confidence.…”

“…24,25 BSGM has been comprehensively validated, and a scalable platform introduced, now enabling clinical translation. 26,27 All rights reserved. No reuse allowed without permission.…”