Given Imaging has started the pivotal PillCam Colon 2 study to treat colorectal cancer in Japan.
The study will compare patients with polyps which have previously been identified by optical colonoscopy with the PillCam Colon 2 capsule endoscopy procedure.
The study’s primary endpoint is to determine polyps greater than or equal to six mm in size.
Results will be read by two groups of readers; one at the investigator sites and the other at a central reading facility.
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.
In order to record the colon, PillCam Colon 2 is ingested by the patient which transmit up to 35 frames per second for approximately 10 hours.
The device data is transferred to a computer that uses RAPID software to compile the video data, which aids physicians to review and report the results of the PillCam study.
The company said the enrollment phase of the trial will be completed by the end of March 2012, with submission to Pharmaceuticals and Medical Devices Agency (PMDA).