Feasibility and accuracy of the Olympus Extra Wide Angle View colonoscope for the detection of colorectal lesions in comparison with the Exera III study
- Conditions
- Adenoma Miss Rate during colonoscopy
- Registration Number
- NL-OMON22448
- Lead Sponsor
- Academic Medical Center Amsterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 429
Inclusion Criteria
Age greater than or equal to 18 years
- High risk for colorectal cancer: FOBT positive, personal or familial (first degree relatives) history of colorectal cancer or colorectal adenoma, patients with symptoms suggestive of colorectal neoplasm: rectal bleeding, recent change in frequency and consistency of stools.
Exclusion Criteria
- Mental or physical condition that can adversely affect the preparation or conduct of the examination or which precludes compliance with the study and / or device instructions.
- Inability to undergo bowel cleansing for colonoscopy.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adenoma detection rate of the Olympus Extra Wide Angle View colonoscope
- Secondary Outcome Measures
Name Time Method - Sensitivity of the Olympus Extra Wide Angle View colonoscope for the detection of advanced colorectal adenomas in comparison to data from the Exera III study, overall and in subgroups (adenoma size, form, location). <br /><br>- Evaluation of caecal insertion time using the Olympus Extra Wide Angle View colonoscope with responsive insertion technology in comparison to caecal insertion times gained during the Exera III study. <br /><br>- Evaluation of ileocaecal valve insertion success using the Olympus Extra Wide Angle View colonoscope in comparison to ileocaecal valve insertion success gained during the Exera III study. <br /> <br>- Evaluation of retroflex view using the Olympus Extra Wide Angle View colonoscope in comparison to the retroflex view gained during the Exera III study. <br /><br>- Adverse events of the Olympus Extra Wide Angle View colonoscope in comparison to the Exera III study. <br>