MORDIS
Research type
Research Study
Full title
A Multicentre, Open, Prospective Study on Modified Resect and Discard Strategy of Small Colonic lesions using WavSTAT4 Optical Biopsy System: The MORDIS study.
IRAS ID
159129
Contact name
Venkat Subramanian
Contact email
Sponsor organisation
SpectraScience Inc
Clinicaltrials.gov Identifier
Research summary
Polyps (small new tissue growths) in the colon (lower bowel) are quite common and may be benign (normal or 'non-suspect') or adenomatous (cancerous/pre-cancerous or 'suspect'). Non-suspect polyps would generally not be removed but suspect polyps do require removal. During screening by colonoscopy for diseases of the colon, it can be difficult to tell the difference between the two types, which leads to the removal and subsequent laboratory testing of many tissue samples. This extensive sampling is often impractical, time-consuming and costly.
The device being tested in this study is the WavSTAT4 Optical Biopsy System. This is an automated diagnostic tool which uses light at a specific wavelength to predict during colonoscopy, whether polyps are non-suspect or suspect. Early studies have found an accuracy of around 96% in predicting the nature of removed polyps. The use of this device during screening for bowel cancer could reduce the number of polyps removed thereby reducing the time taken for the procedure and subsequent savings in laboratory testing of tissue. In this study, the device will be used during routine screening colonoscopy and the predictive results (suspect or non-suspect) made using the device, will be compared to the histological results from the removed tissue to measure the accuracy of the predictions.
The study patients will consist of patients coming to St James' University Hospital, Leeds for standard screening colonoscopy or follow-up colonoscopy after previous polyp removal. The device will be used by a trained investigator during the colonoscopy and any polyps will be removed for analysis, along with some healthy tissue samples for comparison. Patients will be excluded if they have inflammatory bowel disease or hereditary/genetic polyposis syndromes.REC name
West of Scotland REC 5
REC reference
14/WS/1057
Date of REC Opinion
7 Aug 2014
REC opinion
Favourable Opinion