Feasibility and accuracy of the Olympus Extra Wide Angle View colonoscope for the detection of colorectal lesions in comparison with the Exera III study

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 75

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.
- Status 1 and 2 of the ASA classification (fit for colonoscopy)
- Signed informed consent

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.
- Prior abdominal surgery of the gastrointestinal tract (other than uncomplicated appendectomy or cholecystectomy).
- Known or suspicion of inflammatory bowel disease.
- Known large (> 2 cm) colorectal polyp for polypectomy
- Colonic diverticulosis complication within 3 months prior inclusion.
- Very high risk for colorectal cancer, history of extensive polyposis, patients with known genetic disease (Familial Adenomatous Polyposis (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC)).
- Coagulation abnormalities or taking drugs affecting coagulation.
- Life threatening conditions
- Status > 2 of the ASA classification (see Appendix I).
- Renal insufficiency or any contraindication or medication contraindicating the administration of bowel cleansing.
- Female patients who are pregnant or nursing, or of childbearing potential and are not using adequate contraception.
- Participation in another clinical trial within 30 days prior to the Screening Visit or during this study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Adenoma detection rate of the Olympus Extra Wide Angle View colonoscope </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Sensitivity of the Olympus Extra Wide Angle View colonoscope for the<br /><br>detection of advanced colorectal adenomas in comparison to data from the Exera<br /><br>III study, overall and in subgroups (adenoma size, form, location).<br /><br>- Evaluation of caecal insertion time using the Olympus Extra Wide Angle View<br /><br>colonoscope with responsive insertion technology in compariso to caecal<br /><br>insertion times gained during the Exera III study.<br /><br>- Evaluation of ileocaecal valve insertion success using the Olympus Extra Wide<br /><br>Angle View colonoscope in comparison to ileocaecal valve insertion success<br /><br>gained during the Exera III study.<br /><br>- Evaluation of retroflex view using the Olympus Extra Wide Angle View<br /><br>colonoscope in comparison to the retroflex view gained during the Exera III<br /><br>study.<br /><br>- Adverse events of the Olympus Extra Wide Angle View colonoscope in comparison<br /><br>to the Exera III study. </p><br>

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