PillCam Colon Capsule 2® (PCC2) in the Setting of Colorectal Cancer Screening Program

Not Applicable

• Conditions: Colon Cancer
• Interventions: Device: Capsule colonoscopy;

• Registration Number: NCT01744509
• Lead Sponsor: Valduce Hospital

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2011-03
• Status Verified: 2012-12
• Study First Submitted: 2012-12-03
• Study First Submitted QC: 2012-12-05
• Last Update Submitted: 2012-12-05
• Study First Posted: 2012-12-06
• Last Update Posted: 2012-12-06
• Primary Completion: 2013-04
• Study Completion: 2013-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• asymptomatic average risk subjects, participating the regional colon cancer screening program, with positive iFOBT referred for colonoscopy

Exclusion Criteria

• presence of obstructive symptoms
• swallowing disorders
• presence of cardiac pacemaker

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnosis of CRC	Capsule colonoscopy;	All the patients enrolled received all the 3 procedures: capsule colonoscopy; CT-colonography and optical colonoscopy.

Primary Outcome Measures

Name	Time	Method
Sensitivity of PillCam Colon Capsule 2 (R) in identifying significant colonic polyps	participants are followed for about 1 month	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.

Secondary Outcome Measures

Name	Time	Method
to evaluate the tolerability of PCC2 as compared to optical colonoscopy (OC) and CT-colonography (CTC).	participants are followed for about 1 month	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.

Trial Locations

Locations (1)

Ospedale Valduce; 🇮🇹 Como, Italy