Clinical trial · Interventional
Validation of Endoscopic Bimodal Imager for the Bladder Cancer Detection
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CyPaM2 (experimental) | Device | — | UNRESOLVED |
| Strorz (commercial) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Experimental
- description
- 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
- interventionNames
- Device: Strorz (commercial)
- Device: CyPaM2 (experimental)
Primary outcomes (1)
- measure
- Ergonomic comparaison of the two devices
- timeFrame
- 1 day
- description
- Ergonomic of the two devices will be evaluated and compared by using the scale NASA TLX (Hart SG, et al., 1998).
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDAmouroux 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. PMID 31873695