Researchers in a multi-center pivotal trial of M2Aâ Esophageal Capsule Endoscopy (Given Imaging, Yoqneam, Israel) found that this new technology is comparable to upper GI endoscopy for the detection of severe esophageal problems.
The researchers studied 82 patients, including 73 patients with gastroesophageal reflux and 9 patients undergoing surveillance for Barrett's esophagus, a pre-cancerous condition found in up to thirteen percent of GERD patients. Individuals with Barrett's are at an increased risk of developing esophageal adenocarcinoma.
Patients in the study ingested the esophageal capsules in a supine position and subsequently were placed under conscious sedation for an upper GI endosocpy. The investigators interpreting the videos from the esophageal capsules were blinded to the results of the traditional endscopy, and vice versa.
Of the 82 patients, 55 had positive findings on upper GI endoscopy. The esophageal capsule identified esophageal abnormalities in 51 of the 55 patients. The sensitivity of the esophageal capsule for detecting Barrett's was 97 percent and the specificity was 100%. Investigators reported no side effects or ingestion difficulties in any of the 82 patients.
The investigators conclude that the esophageal capsule is convenient, safe and sensitive for visualization of esophageal disorders.