Clinical Studies

OUR SCIENTIFIC APPROACH

Research and Innovation

Clinical studies are essential to validate our innovations and ensure that they meet the highest standards. They allow us to assess the performance and reliability of our devices, optimise our solutions using robust data, compare their performance with reference methods, and evaluate their health-economic benefits.

RESEARCH PROGRAMMES

Our Clinical Studies

Découvrez les études conduites avec nos partenaires pour évaluer VisioCyt® Bladder et faire progresser la prise en charge du cancer de la vessie.

VISIOCYT1
Results published

Evaluation of the diagnostic performance of the VisioCyt® Bladder test in patients with suspected urothelial tumours of the bladder

Study type
French prospective multicentre study
Disease area
Bladder cancer
Sponsor
VitaDX International
MAIN OBJECTIVE

To develop an algorithm capable of distinguishing cancerous from non-cancerous urothelial cells, and to assess the sensitivity and specificity of VisioCyt® Bladder using urine samples.

VISIOCYT2
Manuscript in preparation

Real-world evaluation of the diagnostic performance of the VisioCyt® Bladder test in patients with suspected bladder tumours or undergoing follow-up for a bladder tumour

Study type
French prospective single-centre study
Disease area
Bladder cancer
Sponsor
Institut Paoli-Calmettes
MAIN OBJECTIVE

To assess the negative predictive value (NPV) and sensitivity of urine testing with VisioCyt® Bladder in real-world clinical practice.

DMIA
Statistical analysis

Demonstration of the clinical value of the VisioCyt® Bladder artificial intelligence solution

Study type
European prospective multicentre study
Disease area
Bladder cancer
Sponsor
VitaDX International
MAIN OBJECTIVE

To demonstrate the clinical value of VisioCyt® Bladder compared with conventional urine cytology for detecting recurrence in patients under surveillance for high- or very-high-risk non-muscle-invasive bladder cancer.

AFU NMIBC REGISTRY
Enrolment ongoing

Real-world data collection from patients with non-muscle-invasive bladder cancer (NMIBC)

Study type
French prospective multicentre study
Disease area
Bladder cancer
Sponsor
French Association of Urology (AFU)
MAIN OBJECTIVE

To improve understanding of the treatment and follow-up of NMIBC, and to assess biomarkers in real-world clinical practice that could ultimately reduce unnecessary cystoscopies and improve patient comfort.