pH-integrated ultrathin endoscopy for ambulatory GERD monitoring

The pH-integrated ultrathin endoscopy, known as the EndoMonitor System, represents a groundbreaking innovation for ambulatory gastroesophageal reflux disease (GERD) monitoring. This newly developed device integrates real-time pH measurement with direct video imaging of reflux episodes, addressing limitations of traditional pH-impedance catheters, such as subjective interpretation, delayed analysis, and lack of visual correlation with reflux events.

The EndoMonitor is a 2.8 mm ultrathin transnasal endoscope equipped with an antimony pH electrode and a miniature CMOS camera. It connects to mobile devices for live visualization, allowing simultaneous recording of pH changes and reflux events. Preclinical evaluation included in vitro (porcine esophagus-stomach models) and in vivo (miniature pig) experiments, demonstrating superior detection accuracy compared to conventional pH-impedance catheters. The EndoMonitor achieved 100% detection of distal acid, distal mixed, and horizontal acid reflux, outperforming the catheters, which showed significantly lower detection rates. Additionally, it accurately identified proximal reflux events with over 90% accuracy.

The device offers real-time visualization of reflux episodes and pH drops, enabling objective identification of reflux type, height, duration, and composition (acidic vs. mixed) without the need for post-hoc analysis. It also provides insights into esophageal motility and clearance through documentation of post-reflux swallow-induced peristaltic waves (PSPW), critical for assessing reflux burden and mucosal protection. The safety profile was excellent, with no device malfunctions or adverse effects observed during prolonged monitoring.

While preclinical limitations exist, such as the absence of symptomatic human subjects, planned clinical trials aim to validate the EndoMonitor in conscious humans for long-term use. This dual-mode system offers the potential to redefine GERD diagnostics by combining physiologic data and anatomical imaging, setting a new standard for real-time, visualized reflux assessment.