European, multicenter clinical trial with VisioCyt®, an in vitro diagnostic medical device. VisioCyt® is an innovative solution for the early diagnosis of bladder cancer.
VisioCyt® is based on a patented technology, combining bright-field imaging and artificial intelligence, from a simple urine sample from which the cells are extracted . The main objective of the study is to demonstrate the medical superiority of the VisioCyt® test versus conventional cytology for detecting recurrence of bladder tumors, in patients monitoring non-muscle infiltrating bladder tumors at high and very high risk of progression
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
400
* Cytological and endoscopic examination is planned as part of the usual management of patients under surveillance of Non-muscle invasive bladder cancer (NMIBC), according to the CCAFU guidelines. * Urine collection for conventional cytology and VisioCyt® test
Hôpital Académique ERASME
Anderlecht, Belgium
RECRUITINGCHU Angers
Angers, France
RECRUITINGPerformance of VisioCyt® test vs conventional cytology
Sensibility of the cytological examination of urine with the VisioCyt® test and conventional cytology, all grades and stages combined
Time frame: 24 months
Specificity, positive and negative predictive value for VisioCyt® test and conventional cytology
Specificity of the cytological examination of urine with the VisioCyt® test and conventional cytology, all grades and stages combined
Time frame: 24 months
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RECRUITING...and 5 more locations