NCT05176145

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Vitadx · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Non-muscle Invasive Bladder Cancer (NMIBC)

Interventions

Type	Name	Description
DEVICE	VisioCyt®	* 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

Timeline

• Start date: 2022-04-05
• Primary completion: 2025-02-01
• Completion: 2025-05-31
• First posted: 2022-01-04
• Last updated: 2023-10-13

Locations

15 sites across 3 countries: Belgium, France, Spain