PillCam Colon Capsule 2® (PCC2) in the Setting of Colorectal Cancer Screening Program
Recruitment status was Recruiting
In this study the investigators evaluate the sensitivity of PCC2 (PillCam Colon Capsule 2 (R)) in identifying significant polyps in a CRC (Colo Recatal Cancer) screening program (primary outcome measure).
Each enrolled patient underwent three procedures: colon capsule endoscopy, CT-colonography and optical colonoscopy. In this study the reference standard is represented by the segmental unblinded colonoscopy (the unblinding is based on results of both capsule endoscopy and Ct colonography) The investigators also evaluated the tolerability of PCC2 as compared to optical colonoscopy (OC) and CT-colonography (CTC).
|Study Design:||Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||PillCam Colon Capsule 2® (PCC2) in the Setting of Colorectal Cancer Screening (CRC) Program: Comparison With a New Integrated Reference Standard|
- Sensitivity of PillCam Colon Capsule 2 (R) in identifying significant colonic polyps [ Time Frame: participants are followed for about 1 month ] [ Designated as safety issue: No ]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.
- to evaluate the tolerability of PCC2 as compared to optical colonoscopy (OC) and CT-colonography (CTC). [ Time Frame: participants are followed for about 1 month ] [ Designated as safety issue: No ]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.
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||April 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Diagnosis of CRC
All the patients enrolled received all the 3 procedures: capsule colonoscopy; CT-colonography and optical colonoscopy.
Device: Capsule colonoscopy;
All the enrolled patients underwent all the three study procedures; the colon capsule is the intervention under evaluation; the other 2 procedures (Ct colonography and optcal colonoscopy contribute to build the composite reference standard)
Other Name: Capsule colonoscopy: PillCam Coln Capsule 2
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744509
|Como, Italy, 22100|
|Contact: Giancarlo Spinzi, MD 0039031324145 email@example.com|
|Principal Investigator: Giancarlo Spinzi, MD|
|Sub-Investigator: Emanuele Rondonotti, MD|
|Sub-Investigator: Vittorio Terruzzi|
|Sub-Investigator: Franco Radaelli|
|Principal Investigator: Silvia Paggi|
|Sub-Investigator: Arnaldo Amato|
|Sub-Investigator: Giovanna Mandelli|
|Principal Investigator: Natalia Terreni|
|Sub-Investigator: Lenoci Nicoletta|
|Sub-Investigator: Gianni Imperiali|
|Sub-Investigator: Claudia Borghi|
|Sub-Investigator: Alberto Martegani|
|Principal Investigator:||Giancarlo Spinzi||Gastroenterology Unit; Ospedale Valduce|