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

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Belgium
Hôpital Académique ERASME
RECRUITING
Anderlecht
France
CHU Angers
RECRUITING
Angers
CHU de Caen
RECRUITING
Caen
CHU de Clermont Ferrand
RECRUITING
Clermont-ferrand
CHU Grenoble
RECRUITING
Grenoble
CHU Nantes
RECRUITING
Nantes
Hôpital Bichat-Claude Bernard,
RECRUITING
Paris
Hôpital Pitié-Salpétrière, APHP
RECRUITING
Paris
Clinique la Croix du Sud
RECRUITING
Quint-fonsegrives
CHU de Rennes
RECRUITING
Rennes
CHU Strasbourg
RECRUITING
Strasbourg
Hopital Foch
RECRUITING
Suresnes
CHU Toulouse
RECRUITING
Toulouse
CHU Tours
RECRUITING
Tours
Spain
Pr Maria Jose Ribal
RECRUITING
Barcelona
Contact Information
Primary
Stéphanie Grojean, PhD
DMIA@fondation-force.fr
33 (0)383501921
Time Frame
Start Date: 2022-04-05
Estimated Completion Date: 2025-05-31
Participants
Target number of participants: 400
Treatments
Other: single arm
Only one arm. The urine collection from each patient will be used for VisioCyt® test and conventional cytology
Related Therapeutic Areas
Sponsors
Collaborators: FONDATION FORCE POUR L'INNOVATION ET LA RECHERCHE EN SANTE
Leads: Vitadx

This content was sourced from clinicaltrials.gov