A New Method for Colorectal Cancer Screening: Colon Capsule Endoscopy Compared to Conventional Endoscopy
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|ClinicalTrials.gov Identifier: NCT00991003|
Recruitment Status : Completed
First Posted : October 7, 2009
Last Update Posted : October 7, 2009
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|
|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|
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
- The primary endpoint was the number of cancerous lesions and polyps detected on CCE compared to conventional colonoscopy [ Time Frame: 7 Months ]
- Secondary endpoints were completeness of the exam completeness, patient acceptance and adherence to preparation regimen [ Time Frame: 7 Months ]
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 ClinicalTrials.gov identifier (NCT number): NCT00991003
|Basel, Basel Stadt, Switzerland, 4031|
|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|