Trial Information

PillCam Colon Capsule 2® (PCC2) in the Setting of Colorectal Cancer Screening (CRC) Program: Comparison With a New Integrated Reference Standard

Asymptomatic average risk subjects with positive iFOBT (immunochemical Fecal Occult Blood
Test), participating the regional screening program, were offered to undergo PCC2 (PillCam
Colon Capsule 2 (R)) followed, 21 days later, by CTC and OC performed on the same day. The
number, size and location of significant polyps (>6mm) identified by each procedure were
compared with the reference standard (RS), which was represented by the segmental unblinded
colonoscopy. The unblinding was based on the integration of CTC and PCC2 results. For the
PPC2 the quality of the bowel preparation (adequate/inadequate) and the completeness of the
examination (capsule excreted still working or visualization of the anal verge) were also
reported. In order to evaluate the tolerability, each subject was asked to identify, among
the 3 procedures performed, which was the less tolerated one and which one he would be
willing to repeat.