The Efficiency of Colon Capsule Endoscopy in Colon Cancer Screening
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|ClinicalTrials.gov Identifier: NCT03052335|
Recruitment Status : Recruiting
First Posted : February 14, 2017
Last Update Posted : September 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Colon Cancer||Device: Pillcam® COLON 2 Capsule Procedure: Colonoscopy||Not Applicable|
Multicentre, multidisciplinary (3 gastroenterology units; biostatistics department; cooperation with general practitioners), prospective study is focused on examination of individuals with average colorectal cancer (CRC) risk (asymptomatic, age 50-75 years).
In years 2017 - 2019, there will be 230 persons with positive semi-quantitative immunochemical fecal occult blood tests (FIT; QuikRead, Orion Diagnostica Oy, Finland) with cut-off level 75 ng/ml involved. Every person will be examined by second generation colon capsule endoscopy (CCE2) and optical colonoscopy afterwards.
Main objective is to show that the negative predictive value (NPV) of the CCE2 applied in patients with positive FIT results is sufficient to include this method in the National CRC screening as filter test with aim to reduce the necessity of subsequent optical colonoscopy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||230 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Comparison of the Efficiency of Colon Capsule Endoscopy and Optical Colonoscopy in Patients With Positive Immunochemical Fecal Occult Blood Test|
|Actual Study Start Date :||March 1, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: Pillcam® COLON 2 Capsule and colonoscopy
Persons with positive immunochemical fecal occult blood tests will be examined by second generation colon capsule endoscopy (CCE2) and optical colonoscopy afterwards.
Device: Pillcam® COLON 2 Capsule
The second generation of PillCam colon capsule endoscopy (CCE-2) is 11.6 mm × 31.5 mm in size and has two imagers, that each have a 172° angle of view, allowing for almost 360° visual coverage of the colon. CCE-2 has an adaptive frame rate from 4 to 35 images per second. This means that the camera is able to capture up to 35 pictures while in motion whereas 4 images per second are captured when it is virtually stationary. During the examination the patient wears a sensor array which is attached to the abdomen and a data recorder for storage of the information generated by the ingested capsule. After the examination the data are downloaded into the workstation and a video is generated.
Optical colonoscopy is the standard method for evaluating the colon
- Negative predictive value (NPV) of the CCE2 for large polyps (≥ 10 mm) [ Time Frame: 1 day ]
- CCE2 accuracy for detection of advanced adenomas [ Time Frame: 1 day ]
- CCE2 accuracy for detection of colon cancer [ Time Frame: 1 day ]
- CCE2 and optical colonoscopy acceptance (special questionnaire) [ Time Frame: 1 day ]
- Cost-effectiveness analyses: cost reduction of preventive colonoscopies spared [ Time Frame: 1 day ]
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): NCT03052335
|Contact: Stepan Suchanek, MD., Ph.D.||973208367 ext email@example.com|
|Contact: Michal Voska||773200360 ext firstname.lastname@example.org|
|Military University Hospital||Recruiting|
|Contact: Stepan Suchanek, Ph.D.|
|Study Director:||Stepan Suchanek||Military University Hospital, Prague|