Evaluation of a Second Generation High Definition and Narrow Band Imaging System for the Detection and Characterization of Colorectal Adenomas (EXERA III Colorectal Adenoma Study) - EXERA III Colorectal Adenoma Study

Olympus0 个研究点目标入组 91 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

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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 (see Appendix I)
•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.
•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
•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

发起方

Olympus