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)

Phase 4

Completed

• Conditions: colorectal adenoma; 10017990; 10017991

• Registration Number: NL-OMON39244
• Lead Sponsor: Olympus

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2014-12-09
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 91

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.
• 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>The primary endpoint:<br /><br>Sensitivity of HD2/NBI2 colonoscopy for the detection of colorectal adenomas in<br /><br>comparison to nonHD-nonNBI colonoscopy.</p><br>