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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Other | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strorz (commercial) | Device |
| ||
| CyPaM2 (experimental) |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ESCHWEGE PASCAL, Pr | Institut de Cancérologie de Lorraine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancerologie de Lorraine | Vandœuvre-lès-Nancy | 54519 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31873695 | Background | 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, Eschwege 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. |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| 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 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |