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Completed

NCT Number: NCT02427321

Cystoscopic Imaging Collection and Enhancement pROject

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.

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Key information

Conditions

Urinary Bladder Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Video recording of flexible cystoscopic examination

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

Primary outcomes

  1. Video recording of cystoscopic examination and diagnosis

    Time frame: As time of cystoscopic examination - Visit 1, day 1, diagnostic and pathology information collected for up to 8 weeks following Visit 1

    A set of high quality recorded cystoscopy examinations from 50 to 100 participants. The recordings will be used to develop novel image enhancement software, which is intended to make abnormalities in the bladder easier to identify. The diagnosis reported by the cystoscope operator will be reported at the time of the examination. Pathology derived diagnosis and any other additional information regarding the diagnosis and subsequent treatment will be recorded at 8 weeks following the initial examination (Visit 1, day 1).

Secondary outcomes

  1. Expert opinions of clinical team

    Time frame: Reported following recording of all cystoscopic examinations - approximately 3 months following recruitment of first participant

    Written expert opinions from the clinical team based on structured review of a subset of the recordings in raw and enhanced playback modes, including comments on the quality of the recordings made by the device and their suitability for use as a documentary record of the examination procedure.

  2. Statistical summary

    Time frame: Once data collection from all participants is complete - approximately 5 months after first patient is recruited

    A statistical summary of the inter-observer consistency in reporting 'areas of interest' in raw and enhanced video sequences. This will report on expert and non-expert reviewer results.

  3. Report on 2 and 3 (correspondence between the results of 2) expert opinion and 3)statistical summary, and the diagnostic outcomes logged by the clinic.

    Time frame: Once data collection is complete - approximately 5 months after first patient is recruited

    A report exploring the correspondence between the results of 2) and 3) and the diagnostic outcomes logged by the clinic.

  4. Expert opinion on usability and reliability

    Time frame: Once data collection is complete - approximately 5 months after first patient is recruited

    Written expert opinions from the clinical team which will comment on the usability and reliability of the device compared to existing recording and documenting systems, including whether use of the device has any adverse impact upon patient safety caused by an increase in the duration or disruption of routine cystoscopy procedures.

Sponsors and collaborators

Lead sponsor

Biosignatures Limited

Industry

Collaborators

  • Newcastle-upon-Tyne Hospitals NHS Trust

Registry information

Official study title

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

Acronym: CICERO

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 28, 2015
Registry last updated
Jan 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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