Validation of Endoscopic Bimodal Imager for the Bladder Cancer Detection

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Bladder Cancer

Intervention / Treatment
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* Device: Strorz (commercial)
* Device: CyPaM2 (experimental)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Experimental<br>Patients with a suspicion of a bladder cancer or suspected recurrence of bladder cancer will have a cystoscopy under their care. Patients will be randomized to know the order of carrying out cystoscopy with one or the other medical devices. 24 hours and 48 hours after the exam, a nurse will contact the patient to detect potential adverse effects | Device: Strorz (commercial)<br> <br> Device: CyPaM2 (experimental)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of performing time | Performing time of medical examination with both devices will be evaluated and compared | 1 day | 
| Quality assessment of image | Image quality : sharpness and colorimetry will be assessed by the physician using a self-questionnaire. | 1 day | 
| Quality assessment of device evaluation | Device quality : sensitivity and accuracy will be assessed by the urologist using a self-questionnaire | 1 day | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bladder cancer, Hexvix, Bimodal Endoscopic Imager, Cystoscopy