Validation of Endoscopic Bimodal Imager for the Bladder Cancer Detection

Bladder Cancer Clinical Trial

— CyPaM2  

Official title:

Evaluation of an Innovative Medical Device Made of a Bimodal Endoscopic Imager and of a Software for Panoramic Images Building of the Bladder Inner Wall (French National Research Agency, CyPaM2 Project, ANR-11-TECS-001) (CyPaM2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02800473
• Other study ID #: 2015-A01297-42
• Status: Completed
• Phase: N/A
• Start date: July 4, 2016
• Est. completion date: October 6, 2017

Study information

• Verified date: March 2021
• Source: Institut de Cancérologie de Lorraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 6, 2017
• Est. primary completion date: October 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18 years
• Patient with suspicion of a bladder cancer or a suspected recurrence of a bladder cancer
• Cytological and bacteriological examination of urine culture negative
• Patient must be affiliated to a social security system
• Ability to provide written informed consent patient's legal capacity to consent to study participation and to understand and comply with the requirements of the study

Exclusion Criteria:

• Age < 18 years
• Bladder infection in progress and untreated
• Hemorrhage
• Urethral stenosis
• Contraindication for a cystoscopy examination
• Contraindication to administration of Hexvix (porphyria, hypersensitivity to hexylaminolévulinate or excipient of Hexvix (disodium phosphate dihydrate, potassium dihydrogen phosphate)
• Pregnant or breast feeding females
• Patients deprived of liberty or under supervision

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Device:
• Strorz (commercial)

• CyPaM2 (experimental)

Locations

Country	Name	City	State
France	Institut de Cancerologie de Lorraine	Vandoeuvre-les-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

References & Publications (1)

Amouroux M, Salleron J, Huin-Schohn C, Ali S, Berthaud S, Rizo P, Schneider S, Vever-Bizet C, Bourg-Heckly G, Guillemin F, Le Coupanec P, Galbrun E, Daouk J, Daul C, Blondel W, Eschwège P. Clinical evaluation of a device providing simultaneous white-light and fluorescence video streams as well as panoramic imaging during fluorescence assisted-transurethral resection of bladder cancer. J Opt Soc Am A Opt Image Sci Vis. 2019 Nov 1;36(11):C62-C68. doi: 10.1364/JOSAA.36.000C62. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ergonomic comparaison of the two devices	Ergonomic of the two devices will be evaluated and compared by using the scale NASA TLX (Hart SG, et al., 1998).	1 day
Secondary	Comparison of performing time	Performing time of medical examination with both devices will be evaluated and compared	1 day
Secondary	Quality assessment of image	Image quality : sharpness and colorimetry will be assessed by the physician using a self-questionnaire.	1 day
Secondary	Quality assessment of device evaluation	Device quality : sensitivity and accuracy will be assessed by the urologist using a self-questionnaire	1 day
Secondary	Evaluation of recording capacity of the video sequences to perform real-time image mosaics	Recording capacity of the video sequences to perform real-time image mosaics will be assessed by the physician using a self-questionnaire	1 day