A New Method for Colorectal Cancer Screening: Colon Capsule Endoscopy Compared to Conventional Endoscopy

NCT00991003 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2009-10-07

No results posted yet for this study

Summary

Introduction:

Prevention of colorectal cancer (CRC) is feasible through polypectomy on screening colonoscopy. Patient acceptance remains the main limiting factor for execution. Colon capsule endoscopy (CCE) might be a novel method for large populations.

Aims and methods:

Patients referred for screening means or lower gastrointestinal complaints were included in this single center pilot study. They underwent preparation and then ingested the capsule (PillCam Colon). Standard colonoscopy was performed the next morning. Significance was defined as polyps \>5mm in size. Performance of exams was by independent physician with blinding of results.

Conditions

Interventions

PROCEDURE

Colon capsule endoscopy

The PillCam® Colon Capsule is 11mm x 31mm in size (Figure 1), is equipped with two cameras acquiring pictures from both ends of the capsule at a rate of 4 frames per second (2 pictures per second and camera). The PillCam® Colon Capsule is automatically activated when it is removed from the package. It enters sleeping mode after approximately 10 minutes and starts transmitting again 1 h 45 min later. It has a total operating time of 8 - 10 hours. During the examination the patient wears a sensor array which is attached to the abdominal skin and a data recorder for storage of the information generated by the ingested capsule. After the examination the data are downloaded into the Given Imaging workstation and a video is generated.

PROCEDURE

Conventional Colonoscopy

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Julia B Pilz, MD · University Hospital, Basel, Switzerland

  • Christoph Beglinger, MD · University Hospital, Basel, Switzerland

  • Lukas Degen, MD · University Hospital, Basel, Switzerland

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • Switzerland

Study Locations

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Entities

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 NCT00991003 on ClinicalTrials.gov