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

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ClinicalTrials.gov Identifier: NCT01744509
Recruitment Status : Unknown
Verified December 2012 by Emanuele Rondonotti, Valduce Hospital.
Recruitment status was:  Recruiting
First Posted : December 6, 2012
Last Update Posted : December 6, 2012
Sponsor:
Information provided by (Responsible Party):
Emanuele Rondonotti, 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).


Condition or disease Intervention/treatment Phase
Colon Cancer Device: Capsule colonoscopy; Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: Single (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
Study Start Date : March 2011
Estimated Primary Completion Date : April 2013
Estimated Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Sensitivity of PillCam Colon Capsule 2 (R) in identifying significant colonic polyps [ Time Frame: 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 :
  1. 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 ]
    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.



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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Emanuele Rondonotti, MD, PhD, Valduce Hospital
ClinicalTrials.gov Identifier: NCT01744509     History of Changes
Other Study ID Numbers: 25-2011
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: December 6, 2012
Last Verified: December 2012

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