Abstract
Gastric motility is coordinated, in part, by rhythmic bioelectrical events called slow waves. Dysrhythmic slow waves have been associated with several motility disorders. The current methods for classifying gastric dysrhythmias, via direct-organ mapping, are surgically invasive. To address this limitation, we designed and constructed a minimally invasive, custom gastric mapping device primarily consisting of a 64-electrode spherical-basket mapping catheter, fitted with an internal balloon, which is delivered endoscopically. We successfully deployed this device in n = 13 volunteers, detecting slow waves in n = 12 volunteers, which presented with properties in-line with established physiological ranges confirming device effectiveness. Spatiotemporal propagation maps with >33% electrode coverage were generated in n = 5 volunteers and showed predominantly dysrhythmic activity. This study presents an endoscopic, minimally invasive, high-resolution electrical mapping device complete with first-in-human data from the gastric antrum. With further development, this device could be used to profile and localize gastric dysrhythmias, as a diagnostic tool, and to guide emerging treatments.
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•Minimally invasive, direct organ contact device to record gastric slow waves.•Device records bioelectric signals in high spatial resolution.•First-in-human data presented.•Significant step toward new treatments for functional gastrointestinal disorders.
Gastric motility is coordinated, in part, by rhythmic bioelectrical events called slow waves. Dysrhythmic slow waves with abnormal propagation patterns have been associated with many motility disorders, including functional dyspepsia and gastroparesis, which affect approximately 15% of the global population. No definitive diagnostic test currently exists for these diseases, with diagnosis usually achieved through an “exclusion diagnosis.”
High-resolution electrical mapping of slow waves has emerged as a promising tool for classifying gastric dysrhythmias; however, the current methods for generating detailed maps of gastric electrical activity to guide targeted therapy are surgically invasive. We have developed a custom endoscopic device to allow minimally invasive mapping of gastric slow waves, addressing this limitation. This device could be used in the future to localize gastric dysrhythmias as a diagnostic tool and to guide emerging treatments.
Functional gastrointestinal disorders, such as gastroparesis and functional dyspepsia, affect ∼15% of the global community, yet they are poorly understood and there are limited options for effective diagnosis and treatment of these disorders. This study presents the development and first-in-human application of a minimally invasive, direct organ contact device to record bioelectric activity in the stomach, which is a significant step toward the deployment of new treatments targeting functional gastrointestinal disorders based on underlying electrophysiology.