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.

NIHR CRN portfolio-adopted: portfolio number CANC 4362
Contractors: The Newcastle upon Tyne Hospitals NHS
Foundation Trust (NUTH) as contractors
Led By: Rakesh Heer

Supported by: Biomedical Catalyst grant from Innovate UK

At Videometrics we understand that developing systems for clinical use has to be right. That’s why one of the first things we did was the CICERO study – to ensure that we took the system in the direction clinicians needed, and to generate the data we needed to ensure the system operates as intended.

Current status: A full report of the study is being prepared for submission to Innovate UK and MHRA.

To obtain a copy of report findings when they are available email sarah.groves@biosignatures.com.

Description & Methods

The primary endpoint was to obtain subjective expert clinical opinion on the utility of routine video recording and enhancement in endoscopy sessions. The CICERO study collected data from two types of patient populations.

  1. Haematuria clinics – patients with no history of bladder cancer referred on suspicion they may have a malignancy.
  2. Surveillance clinics – patients who have had a previous diagnosis of bladder cancer and who are being routinely checked for any signs of recurrence.

Briefly, the study involves the recording of video from the endoscopy system in clinics and obtaining diagnosis information from the clinic. The videos are recordings of the routine sessions and as such should not have any consistently different properties to that which we would expect from regular sessions.

Image from cystoscopy as would be seen by the examiner.

The same frame with contrast enhancement applied.

Results & Outcomes

Study results that we can share to demonstrate utility of the Videometrics system.
A full report of the study is being prepared. Study data will be included in printed and on-line posters and oral presentations later this year. A peer reviewed publication is also planned for a later date.

Evidence to support regulatory approval for Videometrics enhanced contrast system in clinics.
Performed a clinical evaluation of the safety, performance and utility of the CICERO device in conformity to the requirements of the European Directive on Medical Devices (93/42/EEC).

A data set of 108 bladder examinations with high-quality video recordings.
Each video has associated age, sex and pathology data for participants. This data is currently undergoing forced choice testing with the goal of generating evidence for the added-value in identifying anomalies using contrast enhanced video data that Videometrics is developing.

If you have any questions please get in touch with us:

Contact us