Wireless esophageal pH capsule for patients with gastroesophageal reflux disease: a multicenter clinical study

To investigate the feasibility and safety of pH capsule to monitor pH in patients with gastroesophageal reflux disease (GERD).

Ninety-one patients with symptoms suggestive of GERD were enrolled in this study, 46 of whom were randomized to the pH capsule group; the remaining 45 patients used the conventional catheter and pH capsule simultaneously. The pH data and traces were recorded via automatic analysis, and capsule detachment was assessed using X-ray images. All of the patients were required to complete a questionnaire regarding tolerance with the capsule.

The capsules were successfully attached on the first attempt, and no early detachment of the capsules was observed. Compared to the 24-h pH data recorded with the conventional catheter, the data collected with the pH capsule showed no significant differences in 24-h esophageal acid exposure. The measurements of esophageal acid exposure over 24 h collected with the two devices showed a significant correlation (r(2) = 0.996, P < 0.001). Capsule detachment occurred spontaneously in 89 patients, and 2 capsules required endoscopic removal due to chest pain. The capsule was associated with less interference with daily activity.

The wireless pH capsule provides a feasible and safe method for monitoring gastroesophageal reflux and therefore may serve as an important tool for diagnosing GERD.