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

This study is currently recruiting participants.
Verified December 2012 by Valduce Hospital
Sponsor:
Information provided by (Responsible Party):
Emanuele Rondonotti, Valduce Hospital
ClinicalTrials.gov Identifier:
NCT01744509
First received: December 3, 2012
Last updated: December 5, 2012
Last verified: December 2012
History of Changes
  Purpose

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).


Condition Intervention
Colon Cancer
 Device: Capsule colonoscopy;

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Valduce Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 35
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)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744509

Locations
Italy
Ospedale Valduce Recruiting
Como, Italy, 22100
Contact: Giancarlo Spinzi, MD     0039031324145     gispinz@tin.it    
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            
Sponsors and Collaborators
Valduce Hospital
Investigators
Principal Investigator: Giancarlo Spinzi Gastroenterology Unit; Ospedale Valduce
  More Information

No publications provided

Responsible Party: Emanuele Rondonotti, MD, PhD, Valduce Hospital
ClinicalTrials.gov Identifier: NCT01744509     History of Changes
Other Study ID Numbers: 25-2011
Study First Received: December 3, 2012
Last Updated: December 5, 2012
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 23, 2013