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

NCT01744509 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2012-12-06

No results posted yet for this study

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).

Conditions

Interventions

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)

Sponsors & Collaborators

  • Valduce Hospital

    lead OTHER

Principal Investigators

  • Giancarlo Spinzi · Gastroenterology Unit; Ospedale Valduce

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01744509 on ClinicalTrials.gov