Given Imaging’s European multicenter study of PillCam COLON 2 confirmed that the second-generation PillCam COLON capsule has higher sensitivity for colorectal polyp detection than the first generation technology.
The PillCam COLON 2 video capsule is equipped with two miniature color video cameras (one on each end), a battery and an LED light source.
PillCam COLON 2, which measures 11 mm X 31 mm, is designed to be ingested by the patient and transmit up to 35 frames per second for approximately 10 hours to a recording device worn by the patient.
Data are transferred from the device to a computer that uses RAPID software to compile the video data and enable the physician to review and report the results of the PillCam study.
The prospective study conducted at eight European sites compared colon capsule endoscopy with conventional colonoscopy for the detection of colorectal polyps or masses greater than or equal to 6 mm in size in a cohort of patients at average or increased risk of colorectal neoplasia.
Colonoscopy was independently performed within 10 hours after capsule ingestion or the next day.
Colon capsule endoscopy sensitivity and specificity for detecting patients with polyps greater than or equal to 6 mm and greater than or equal to 10 mm in size were assessed.
Capsule-positive but colonoscopy-negative cases were counted as ‘false-positive.’
Data from 109 out of 117 patients were analyzed.
Given Imaging president and CEO Homi Shamir said they are pleased that the results of this study confirm PillCam COLON 2’s high sensitivity for detecting polyps of clinically meaningful size.
"In fact, PillCam COLON detected 5 polyps that colonoscopy did not. We believe that we have a strong product and have built the learnings from the European trial into the design of our multicenter US pivotal study which will shortly be underway," Shamir said.