CICERO Version 1
Research type
Research Study
Full title
Cystoscopic Imaging Collection and Enhancement pROject (CICERO): A prospective, non-randomised, observational proof-of-concept study of flexible cystoscopic examination recordings from a symptomatic adult population
IRAS ID
162123
Contact name
Sarah Groves
Contact email
Sponsor organisation
Biosignatures Ltd
Duration of Study in the UK
0 years, 4 months, 2 days
Research summary
This study will collect video recordings of flexible cystoscopy examinations, medical history and diagnosis information, from up to 100 participants in order to develop a new computer system for recording and reviewing images of the bladder, and to assess the utility of this system.
Flexible cystoscopy is commonly used in the diagnosis and post-treatment care of bladder cancer, the 7th most common cancer in the UK. While the equipment to record bladder examinations exists, it is not simple or quick to use so examinations are rarely recorded. Methods of enhancing the images obtained during these examinations also exist but these are generally hardware based, requiring specific equipment, or use a fluorescent dye and special endoscope, which is expensive for the clinical service provider, inconvenient for the patient and may cause allergic reactions.
The new proof-of–concept device will record high-definition video in a loss-less format to a computer hard-drive from any existing cystoscopy equipment to which it can be connected. Additionally, the device incorporates a foot pedal which allows the operator to “bookmark” points of interest during the examination. These points are marked in the recorded video data file and aid later navigation and review of examination session videos.
The recordings will be used to develop novel image enhancement software, which is intended to make abnormalities in the bladder easier to identify. Once the software has been developed, the enhanced and un-enhanced videos will be reviewed by experts (clinical urology specialists) and non-experts (other healthcare staff and lay-people), who will be asked to report areas of interest in the videos, without knowledge of the diagnosis for each examination. A statistical analysis of reporting of areas of interest by expert and non-expert reviewers will be produced, to assess the usefulness of the software image enhancement in identifying abnormalities in the bladder.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
15/NE/0072
Date of REC Opinion
3 Mar 2015
REC opinion
Favourable Opinion