NCT02427321

Cystoscopic Imaging Collection and Enhancement pROject

Cystoscopic Imaging Collection and Enhancement pROject: A Prospective, Non-randomised, Observational Proof-of-concept Study of Flexible Cystoscopic Examination Recordings From a Symptomatic Adult Population

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 123 (actual)
• Sponsor: Biosignatures Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will collect video recordings of routine flexible cystoscopy examinations, medical history and diagnosis information, from up to 100 participants who have a history of bladder cancer, or symptoms suggestive of bladder cancer, in order to develop a new computer system for recording and reviewing images of the bladder, and to assess the utility of this system.

Detailed description

Flexible cystoscopy is commonly used in the diagnosis and post-treatment care of bladder cancer, the 7th most common cancer in the United Kingdom. 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 lossless 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 laypeople), 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.

Conditions

• Urinary Bladder Neoplasms

Interventions

Type	Name	Description
DEVICE	Video recording of flexible cystoscopic examination	The video feed from the flexible cystoscopic examination will be recorded for all participants in the study. Proof-of-concept device will record high-definition video in a lossless format to a computer hard-drive from any existing cystoscopy equipment

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-10-01
• Completion: 2015-10-01
• First posted: 2015-04-28
• Last updated: 2016-01-14