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

  • STATUS
    Recruiting
  • End date
    May 31, 2025
  • participants needed
    400
  • sponsor
    Vitadx
Updated on 4 October 2022

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.

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

Details
Condition Non-muscle Invasive Bladder Cancer (NMIBC)
Treatment VisioCyt®
Clinical Study IdentifierNCT05176145
SponsorVitadx
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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 primary diagnosis should be less than or equal to 12 months

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
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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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