Demonstration of the Medical Interest of the VisioCyt® Artificial Intelligence Test (DMIA)

Vitadx

Status: Enrolling

Conditions: Non-muscle Invasive Bladder Cancer (NMIBC)

Treatments: Device: VisioCyt®

Study type: Interventional

Funder types: Other

Identifiers

NCT05176145

DMIA-2021

Details and patient eligibility

About

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

Full 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

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

single arm

Other group

Description:

Only one arm. The urine collection from each patient will be used for VisioCyt® test and conventional cytology

Treatment:

Device: VisioCyt®