Cystoscopic Imaging Collection and Enhancement pROject

NCT ID: NCT02427321

Last Updated: 2016-01-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 123 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2015-10-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cystoscopy cohort

Video recording of flexible cystoscopic examination. All participants enrolled on the study will have video from their flexible cystoscopic examination recorded.

Diagnosis and pathology information will be collected from the participants medical notes for a period of eight weeks following the recorded cystoscopy.

Video recording of flexible cystoscopic examination

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• patients scheduled to undergo cystoscopy examination as they are considered to possibly have undiagnosed bladder cancer, or;
• patients scheduled to undergo a post-treatment follow-up or routine surveillance cystoscopy examination, having previously been treated for bladder cancer; and
• Have provided written informed consent agreeing to participation in the study prior to any study-specific procedures being carried out.

Exclusion Criteria

• patients who are incapable of providing written informed consent agreeing to participation in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Newcastle-upon-Tyne Hospitals NHS Trust

OTHER

Sponsor Role: collaborator

Biosignatures Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rakesh Heer, PhD FRCS

Role: PRINCIPAL_INVESTIGATOR

Newcastle University, NICR

Other Identifiers

PR-14056

Identifier Type: -

Identifier Source: org_study_id