NCT01744509

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

December 6, 2012

Status Verified

December 1, 2012

Enrollment Period

2.1 years

First QC Date

December 3, 2012

Last Update Submit

December 5, 2012

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (1)

  • Sensitivity of PillCam Colon Capsule 2 (R) in identifying significant colonic polyps

    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 Outcomes (1)

  • to evaluate the tolerability of PCC2 as compared to optical colonoscopy (OC) and CT-colonography (CTC).

    participants are followed for about 1 month

Study Arms (1)

Diagnosis of CRC

OTHER

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

Device: Capsule colonoscopy;

Interventions

Capsule colonoscopy;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)

Also known as: Capsule colonoscopy: PillCam Coln Capsule 2
Diagnosis of CRC

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • asymptomatic average risk subjects, participating the regional colon cancer screening program, with positive iFOBT referred for colonoscopy

You may not qualify if:

  • presence of obstructive symptoms
  • swallowing disorders
  • presence of cardiac pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Valduce

Como, 22100, Italy

RECRUITING

Related Publications (1)

  • 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.

    PMID: 24398064DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Giancarlo Spinzi

    Gastroenterology Unit; Ospedale Valduce

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

December 3, 2012

First Posted

December 6, 2012

Study Start

March 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

December 6, 2012

Record last verified: 2012-12

Locations

IT(1)