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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00991003
Recruitment Status : Completed
First Posted : October 7, 2009
Last Update Posted : October 7, 2009
Information provided by:
University Hospital, Basel, Switzerland

Brief Summary:


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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Procedure: Colon capsule endoscopy Procedure: Conventional Colonoscopy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: A New Method for Colorectal Cancer Screening: Colon Capsule Endoscopy Compared to Conventional Endoscopy
Study Start Date : November 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Colon capsule endoscopy and colonoscopy
Patients underwent CCE on day 1 and conventional colonoscopy on day 2
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.
Other Name: Pillcam Colon Capsule

Procedure: Conventional Colonoscopy

Primary Outcome Measures :
  1. The primary endpoint was the number of cancerous lesions and polyps detected on CCE compared to conventional colonoscopy [ Time Frame: 7 Months ]

Secondary Outcome Measures :
  1. Secondary endpoints were completeness of the exam completeness, patient acceptance and adherence to preparation regimen [ Time Frame: 7 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • male/female above the age of 50 years with symptoms (Indication for screening)
  • male/female above the age of 50 years without symptoms
  • male/female younger than 50 years without symptoms but with a positive family history for colorectal cancer (CRC) (Indication for screening)

Exclusion Criteria:

  • CRC in the patient's history
  • cardiac pacemaker
  • contraindications for sodium phosphate solution (Colophos®)
  • risk factors for capsule retention including surgical intestinal anastomosis, Crohn's disease, diverticulitis and radiologically suspected bowel obstruction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00991003

University Hospital
Basel, Basel Stadt, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Principal Investigator: Julia B Pilz, MD University Hospital, Basel, Switzerland
Study Director: Christoph Beglinger, MD University Hospital, Basel, Switzerland
Study Chair: Lukas Degen, MD University Hospital, Basel, Switzerland

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Julia Pilz, Resident, University Hospital Basel, Gastroenterology, University Hospital Basel Identifier: NCT00991003     History of Changes
Other Study ID Numbers: EKBB25407
First Posted: October 7, 2009    Key Record Dates
Last Update Posted: October 7, 2009
Last Verified: October 2009

Keywords provided by University Hospital, Basel, Switzerland:
Colon Capsule Endoscopy
Colorectal Cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases