Pilot Validation of a New Wireless Patch System as an Ambulatory, Noninvasive Tool That Measures Gut Myoelectrical Signa

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ORIGINAL ARTICLE

Pilot Validation of a New Wireless Patch System as an Ambulatory, Noninvasive Tool That Measures Gut Myoelectrical Signals: Physiologic and Disease Correlations Lindsay Axelrod1 · Steve Axelrod1 · Anand Navalgund1 · George Triadafilopoulos2  Received: 28 June 2020 / Accepted: 6 October 2020 © Springer Science+Business Media, LLC, part of Springer Nature 2020

Abstract Background and Aims  Limited means exist to assess gastrointestinal activity in a noninvasive, objective way that is highly predictive of underlying motility disorders. The aim of this paper is to demonstrate the feasibility of recording myoelectric gastrointestinal activity by cutaneous patches and to correlate myoelectric signals with gastrointestinal function in various clinical settings. Methods  A novel wireless patch system (WPS) (G-Tech Medical) that acquires gastrointestinal myoelectrical signals was placed on the patients’ anterior abdomens. Data were transmitted wirelessly to a mobile device with a user interface and forwarded to a cloud server where processing algorithms identified episodes of motor activity, quantified their parameters, and nominally assigned them to specific gastrointestinal organs based on their frequencies. Results  The inherent reproducibility of the WPS measurement technique itself and from the underlying gut activity, coupled with source validation and sensitivity to changes in gut activity in several physiologic and pathologic states, demonstrates its feasibility, safety, and performance in clinical settings. Conclusions  The novel WPS technology, measuring myoelectric intestinal activity noninvasively and continuously over multiple days, is feasible in a wide range of clinical settings, highlighting its promise in the diagnosis and management of motility disorders. Further research is required for more extensive validation and to determine how best to employ this information to optimize patient care. Keywords  Myoelectrical recordings · Gut motility · Constipation · Gastroparesis

Introduction The frequency of functional gastrointestinal disorders (FGID) is quite disturbing worldwide. The number of yearly office visits (in millions) in the USA for abdominal pain is 15, diarrhea, 4.5, constipation, 2.4, and altered bowel habits, 1.3, while the worldwide prevalence of irritable bowel syndrome (IBS) is 11%. In turn, the prevalence of chronic idiopathic constipation is 14% [1, 2]. * George Triadafilopoulos [email protected] 1



G‑Tech Medical, Fogarty Institute for Innovation, 2495 Hospital Drive, Suite 300, Mountain View, CA 94040, USA



Division of Gastroenterology and Hepatology, Stanford University School of Medicine, 430 Broadway St., Pavilion C, 3rd Floor, GI Suite, Redwood City, CA 94063, USA

2

Over many decades, significant technological developments have allowed the study of the gut and its underlying motility patterns and have included ingestion of radiopaque markers [3], gastrointestinal scintigraphy [4], breath tests [5], and wireless motility capsules [6]. Other tests that study the