Demonstration of the Medical Interest of the VisioCyt® Artificial Intelligence Test

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05176145

Acronym

DMIA

Enrollment

400

Registered

2022-01-04

Start date

2022-04-05

Completion date

2025-05-31

Last updated

2023-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-muscle Invasive Bladder Cancer (NMIBC)

Keywords

NMIBC, recurrence

Brief summary

European, multicenter clinical trial with VisioCyt®, an in vitro diagnostic medical device. VisioCyt® is an innovative solution for the early diagnosis of bladder cancer.

Detailed description

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

Interventions

DEVICEVisioCyt®

* 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Performance of VisioCyt® test vs conventional cytology	24 months	Sensibility of the cytological examination of urine with the VisioCyt® test and conventional cytology, all grades and stages combined

Secondary

Measure	Time frame	Description
Specificity, positive and negative predictive value for VisioCyt® test and conventional cytology	24 months	Specificity of the cytological examination of urine with the VisioCyt® test and conventional cytology, all grades and stages combined

Countries

Belgium, France, Spain

Contacts

Primary ContactStéphanie Grojean, PhD

DMIA@fondation-force.fr33 (0)383501921

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026