Clinical Study to Assess the Performance of the Invendo C20 Colonoscope System in Persons Undergoing Colorectal Cancer Screening at Average Risk for CRC

Invendo Medical GmbH2 个研究点分布在 1 个国家开始时间: 2009年11月最近更新: 2010年1月22日

适应症

试验速览

The purpose of the study is to evaluate efficacy (i.e. reaching the cecum) and safety of the Invendo C20 Colonoscopy System

•Screenees, i.e. asymptomatic persons willing to undergo screening colonoscopy, at average risk for colorectal cancer
•Age between 50-75 years
•Signed informed consent

•Family or personal history of colorectal neoplasia including familial adenomatous polyposis (FAP) or hereditary non-polyposis colorectal cancer
•Prior colonoscopy within preceding 10 years
•A suspected diagnosis of inflammatory bowel disease, bowel obstruction, acute diverticulitis, known severe diverticulosis or any known large bowel disease
•Clinically significant cardiovascular or pulmonary diseases
•Gastrointestinal-tract related symptoms, complaints or diseases suggesting performance of colonoscopy (no screening cases)
•Cancer or other life threatening diseases or significant chronic conditions
•Blood clotting disorders and /or anti-coagulant therapy including aspirin within the last 7 days
•Known pregnancy or positive screening pregnancy tests
•Previous abdominal surgery except for uncomplicated cholecystectomy, appendectomy or minor pelvic surgery (e.g. hernia repair, oophorectomy)
•Morbid obesity (BMI > 40)
•Clinically significant abnormal screening laboratory findings
•Clinically significant abnormal screening ECG findings
•Drug abuse or alcoholism
•Inability of the screenee to adequately communicate
•Screenees under custodial care
•Participation in a clinical study within the last 30 days

发起方

Invendo Medical GmbH

申办方类型

Industry

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