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

Academisch Medisch Centrum0 个研究点目标入组 75 人开始时间: 待定最近更新: 2024年6月11日

适应症

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•- 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

•- 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.

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