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Evaluation of Diagnostic Performance of VisioCyt® Test, in Case of Suspicion of Urothelial Bladder Tumors

NCT02966691 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1360

Last updated 2022-01-06

No results posted yet for this study

Summary

This clinical study is designed to evaluate the diagnostic performance of VisioCyt test, which would improve the early diagnosis of bladder cancer in order to optimize the management of individual patients as part of a cancer diagnostic monitoring. The diagnostic method of VisioCyt® device is based on the analysis by transmission and fluorescence, of urinary cytology slides prepared according to the protocol VisioCyt.

Conditions

Interventions

OTHER

VisioCyt® diagnostic test

The cytology slides obtained from the current practice will be compared to the slides obtained with the Visiocyt protocol, for each arm.

Sponsors & Collaborators

  • FONDATION FORCE POUR L'INNOVATION ET LA RECHERCHE EN SANTE

    collaborator UNKNOWN

  • SATT Paris Saclay

    collaborator UNKNOWN

  • Vitadx

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-24
Primary Completion
2020-12-31
Completion
2021-01-16

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02966691 on ClinicalTrials.gov