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

NCT ID: NCT01744509

Last Updated: 2012-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-04-30

Brief Summary

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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

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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.

Conditions

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Colon Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Diagnosis of CRC

All the patients enrolled received all the 3 procedures: capsule colonoscopy; CT-colonography and optical colonoscopy.

Group Type OTHER

Capsule colonoscopy;

Intervention Type DEVICE

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)

Interventions

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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)

Intervention Type DEVICE

Other Intervention Names

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Capsule colonoscopy: PillCam Coln Capsule 2

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Valduce Hospital

OTHER

Sponsor Role lead

Responsible Party

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Emanuele Rondonotti

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giancarlo Spinzi

Role: PRINCIPAL_INVESTIGATOR

Gastroenterology Unit; Ospedale Valduce

Locations

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Ospedale Valduce

Como, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Giancarlo Spinzi, MD

Role: primary

References

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Rondonotti E, Borghi C, Mandelli G, Radaelli F, Paggi S, Amato A, Imperiali G, Terreni N, Lenoci N, Terruzzi V, Baccarin A, Martegani A, Spinzi G. Accuracy of capsule colonoscopy and computed tomographic colonography in individuals with positive results from the fecal occult blood test. Clin Gastroenterol Hepatol. 2014 Aug;12(8):1303-10. doi: 10.1016/j.cgh.2013.12.027. Epub 2014 Jan 5.

Reference Type DERIVED
PMID: 24398064 (View on PubMed)

Other Identifiers

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25-2011

Identifier Type: -

Identifier Source: org_study_id