The Efficiency of Colon Capsule Endoscopy in Colon Cancer Screening
NCT ID: NCT03052335
Last Updated: 2019-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
230 participants
INTERVENTIONAL
2017-03-01
2019-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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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.
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.
Colonoscopy
Optical colonoscopy is the standard method for evaluating the colon
Interventions
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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.
Colonoscopy
Optical colonoscopy is the standard method for evaluating the colon
Eligibility Criteria
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Inclusion Criteria
* asymptomatic (no enterorhagy, weight loss or anemia)
* signed informed consent with the study and with colonoscopy
Exclusion Criteria
* having first degree relatives diagnosed with colorectal cancer at age ˂ 60 years
* FAP, HNPCC and other hereditary CRC syndromes probands
* positive personal medical history of colorectal neoplasia (advanced adenomatous polyp, colorectal cancer)
* recent diagnostic, follow-up or preventive colonoscopy in ≤ 3 years (FOBT-positive colonoscopy, screening colonoscopy)
* colonoscopy contraindication
* severe acute inflammatory bowel disease
* severe comorbidities; likely non-compliance of the patient
* no informed consent signed (with the study and/or with colonoscopy)
50 Years
75 Years
ALL
Yes
Sponsors
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Masaryk University
OTHER
Institute for Clinical and Experimental Medicine
OTHER_GOV
University Hospital Hradec Kralove
OTHER
Military University Hospital, Prague
OTHER
Responsible Party
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Stepan Suchanek, MD., Ph.D.
Head of Department of Gastrointestinal Endoscopy
Principal Investigators
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Stepan Suchanek
Role: STUDY_DIRECTOR
Military University Hospital, Prague
Locations
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Military University Hospital
Prague, , Czechia
Countries
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Central Contacts
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Facility Contacts
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Stepan Suchanek, Ph.D.
Role: primary
Other Identifiers
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16-29614A
Identifier Type: -
Identifier Source: org_study_id
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