Clinical trial · Interventional
Demonstration of the Medical Interest of the VisioCyt® Artificial Intelligence Test
NCT05176145CI-TRIAL-00070471DMIAunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
European, multicenter clinical trial with VisioCyt®, an in vitro diagnostic medical device. VisioCyt® is an innovative solution for the early diagnosis of bladder cancer.
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 |
|---|---|---|---|
| Non-muscle Invasive Bladder Cancer (NMIBC) | Non-Muscle Invasive Bladder Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VisioCyt® | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- single arm
- description
- Only one arm. The urine collection from each patient will be used for VisioCyt® test and conventional cytology
- interventionNames
- Device: VisioCyt®
Primary outcomes (1)
- measure
- Performance of VisioCyt® test vs conventional cytology
- timeFrame
- 24 months
- description
- Sensibility of the cytological examination of urine with the VisioCyt® test and conventional cytology, all grades and stages combined
Secondary outcomes (1)
- measure
- Specificity, positive and negative predictive value for VisioCyt® test and conventional cytology
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years old and autonomous * Patient understanding national language well and able to understand the protocol. * Patient information and informed consent signature before the start of the study * Patients under surveillance of Non-muscle invasive bladder cancer (NMIBC) at high and very high risk of progression, whatever the stage on the basis of a histological result. The diagnosis (primary or recurrence) should be less than or equal to 24 months (the last histology result confirming a bladder cancer with high or very high risk of recurrence is taken into account). Exclusion Criteria: * Patients who have had total bladder resection or bladder reconstruction * Age \<18 years old * Person deprived of liberty or under guardianship (including curatorship) * Bladder cancer outside of urothelial carcinoma * Associated high urinary tract carcinoma * Kidney transplant patient (BK virus) * Pelvic radiotherapy patient (prostate cancer) * Patients with or under surveillance of a muscle-infiltrating bladder tumor
References
Publications (0)
Data not yet available
No reference posted for this study.