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

December 5, 2012 updated by: Emanuele Rondonotti, Valduce Hospital

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Como, Italy, 22100
        • Recruiting
        • Ospedale Valduce
        • Contact:
          • Giancarlo Spinzi, MD
          • Phone Number: 0039031324145
          • Email: 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • Capsule colonoscopy: PillCam Coln Capsule 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
participants are followed for about 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
participants are followed for about 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valduce Hospital

Investigators

  • Principal Investigator: Giancarlo Spinzi, Gastroenterology Unit; Ospedale Valduce

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

April 1, 2013

Study Completion (Anticipated)

April 1, 2013

Study Registration Dates

First Submitted

December 3, 2012

First Submitted That Met QC Criteria

December 5, 2012

First Posted (Estimate)

December 6, 2012

Study Record Updates

Last Update Posted (Estimate)

December 6, 2012

Last Update Submitted That Met QC Criteria

December 5, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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