Given Imaging has reported positive data from a prospective, blinded, multicentre study that investigated the sensitivity of PillCam Colon 2 video capsule for detecting clinically relevant polypoid lesions.
The capsule is designed to be ingested by the patient. It is fitted with two miniature colour video cameras (one on each end), a battery and an LED light source.
The study enrolled 117 patients and confirmed that the second-generation PillCam Colon capsule demonstrated sensitivity and specificity for detecting polyps greater than or equal to 6 mm and greater than or equal to 10mm.
It also found that per-patient colon capsule endoscopy sensitivity for polyps greater than or equal to 6 mm and greater than or equal to 10mm was 84% and 88%, with specificities of 64% and 95%, respectively.
In addition, colon capsule endoscopy also detected all three invasive carcinomas.
Professor Cristiano Spada of Catholic University in Rome, Italy, said that colon capsule endoscopy is a patient-friendly, minimally invasive technology that enables visualisation of the colon without sedation or air insufflation.
"The high sensitivity for clinically relevant lesions shown in the study demonstrates the value of this tool to complement colonoscopy, which may ultimately result in improved patient compliance with colorectal screening guidelines,” Spada added.
The company has initiated a multicentre pivotal study for PillCam Colon 2, which will support the company’s planned 510(k) submission to the US Food and Drug Administration.