|- candidate number||17559|
|- NTR Number||NTR4536|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||23-apr-2014|
|- Secondary IDs||NL46414.018.13 |
|- Public Title||Feasibility and accuracy of the Olympus Extra Wide Angle View colonoscope for the detection of colorectal lesions in comparison with the Exera III study|
|- Scientific Title||Feasibility and accuracy of the Olympus Extra Wide Angle View colonoscope for the detection of colorectal lesions in comparison with the Exera III study|
|- hypothesis||Increased adenoma detection rate due to the enlarged colonoscopic view|
|- Healt Condition(s) or Problem(s) studied||Adenomas, Colonoscopy|
|- 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 (see Appendix I)
- 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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-aug-2014|
|- planned closingdate|
|- Target number of participants||429|
|- Interventions||Colonoscopy with extra wide angle view colonoscope|
|- Primary outcome||Adenoma detection rate of the Olympus Extra Wide Angle View colonoscope |
|- Secondary outcome||- 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). |
- 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.
- 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.
- Evaluation of retroflex view using the Olympus Extra Wide Angle View colonoscope in comparison to the retroflex view gained during the Exera III study.
- Adverse events of the Olympus Extra Wide Angle View colonoscope in comparison to the Exera III study.
|- Timepoints||01-03-2015 data analysis|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES||Prof MD Thomas Rösch|
|- CONTACT for SCIENTIFIC QUERIES||Prof MD Thomas Rösch|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Olympus Medical Systems|
|- Brief summary||Colonoscopy is the gold standard for finding colorectal cancers and precursor lesions, adenomas. Unfortunately recent studies show there is still a high adenoma miss-rate with the current endoscopic techniques. Some adenomas hide behind valve and are therefore missed. Olympus developed a new device that provides the endoscopist an enlarged view. The expectation is that due to this enlarged view more adenomas are detected compared to conventional colonoscopy. The results will be compared with the results of the EXERA III study |
|- Main changes (audit trail)|
|- RECORD||23-apr-2014 - 21-mei-2014|