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Validation of Endoscopic Bimodal Imager for the Bladder Cancer Detection

2016-06-15 17:53:22 | BioPortfolio

Summary

This study evaluates the therapeutic value of: (i) simultaneous endoscopic visualization of the inner bladder using white light and blue light excitations and (ii) high resolution panoramic images of the bladder inner wall.

All participants will undergo fluorescence cystoscopy: the first half using first a reference medical device for fluorescence cystoscopy already on the market then using the innovative device specifically developped for the CyPaM2 project.

The other half will undergo fluorescence cystoscopy using first the innovative then the reference medical device.

Description

An innovative medical device was developped by the CyPaM2 project's partners.This device is made of a hardware and of a software part: (i) an imager (light source and sensors) for simultaneous and colocalized visualisation of the bladder using white light and blue light for fluorescence excitation and (ii) a mosaicing software for automatic building of high-resolution panoramic images of the bladder inner wall. The medical device's qualitative (human engineering, images qualitty) and quantitative (medical examination and panoramic images building durations) specifications will be evaluated during the clinical trial in comparison with a reference medical device already on the market. The main goals are to achieve (i) better sensitivity of bladder cancers' cystocopic diagnosis and shorter medical examination durations thanks to the simultaneous visualization of the bladder inner wall with white and blue lights and (ii) better patients' follow up thanks to the high resolved panoramic images.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Conditions

Bladder Cancer

Intervention

Strorz (commercial), CyPaM2 (experimental)

Status

Not yet recruiting

Source

Institut de Cancérologie de Lorraine

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-06-15T17:53:22-0400

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