Clinical trial · Interventional
The Efficiency of Colon Capsule Endoscopy in Colon Cancer Screening
The Comparison of the Efficiency of Colon Capsule Endoscopy and Optical Colonoscopy in Patients With Positive Immunochemical Fecal Occult Blood Test
NCT03052335CI-TRIAL-00036538unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Main objective is to improve colorectal cancer (CRC) screening programme in the Czech Republic and decrease the disease incidence and mortality. The secondary aim is to verify the effectiveness of incorporation of the new minimally invasive device in the prevention programme.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colonoscopy | Procedure | — | UNRESOLVED |
| Pillcam® COLON 2 Capsule | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Pillcam® COLON 2 Capsule and colonoscopy
- description
- Persons with positive immunochemical fecal occult blood tests will be examined by second generation colon capsule endoscopy (CCE2) and optical colonoscopy afterwards.
- interventionNames
- Device: Pillcam® COLON 2 Capsule
- Procedure: Colonoscopy
Primary outcomes (1)
- measure
- Negative predictive value (NPV) of the CCE2 for large polyps (≥ 10 mm)
- timeFrame
- 1 day
Secondary outcomes (4)
- measure
- CCE2 accuracy for detection of advanced adenomas
- timeFrame
- 1 day
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * age 50 - 75 years * asymptomatic (no enterorhagy, weight loss or anemia) * signed informed consent with the study and with colonoscopy Exclusion Criteria: * CRC high-risk group patients * 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)
References
Publications (0)
Data not yet available
No reference posted for this study.