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Clinical trial Recruiting at 5 sites Observational Men only

HIFU with Focal One for Prostate Cancer: Real-Life Data Registry

Official title: Clinical Data Collection of Patients Treated With High Intensity Focused Ultrasound (HIFU) by the Focal One for Their Prostate Cancer.

Run by Edap Tms S.a. · NCT07645872 · Data updated 2026-11-12

This registry collects real-world data from men treated with the Focal One HIFU device to see how well it works and how safe it is.

More Prostate Cancer trials

Quick facts

Study typeObservational
SexMen only
Enrollment3000 (estimated)
SponsorEdap Tms S.a.
Industry-sponsored
Locations5 sites (Aix-en-Provence and 4 other locations)
StatusRecruiting
StartedFebruary 1, 2023
Main results expectedApril 2031
Study endsApril 2031
Registry record updatedJune 12, 2026
Trial IDNCT07645872 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Men with prostate cancer who were treated with the Focal One HIFU device and who consent to have their clinical data included.

Probably not a fit

Patients who did not receive HIFU with the Focal One device or who did not consent to data collection may not benefit from the findings.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational registry that combines prospective and retrospective data for patients with prostate cancer treated using the Focal One high-intensity focused ultrasound device. It aims to document clinical performance and safety of the device in routine practice. Data will be collected from multiple sites to reflect real-world outcomes, including treatment details and follow-up information. Participation requires patient consent for data collection and is limited to those who received the Focal One device. The study does not specify a fixed intervention beyond the use of HIFU with Focal One.

Why it matters

Potential benefit: If successful, the registry could provide evidence on safety and effectiveness of Focal One HIFU in everyday care and inform future practice.

How similar studies have gone: Other registries and observational studies have explored HIFU approaches, supporting the value of real-world data; this study adds device-specific real-life experience.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Being treated for prostate cancer with the Focal One device
* Patient does not object and consent\* to the collection of clinical data in the registry

Exclusion Criteria:

* Patient deprived of liberty following a judicial or administrative decision
* Patient under guardianship or curatorship \* if applicable according to local regulation

Where it's running

  • Hôpital privé Aix en provence
    Aix-en-Provence, France     Recruiting
  • Clinique Saint vincent
    Besançon, France     Recruiting
  • Hôpital Civil Colmar
    Colmar, France     Recruiting
  • Hôpital Edouard Heriot
    Lyon, France     Recruiting
  • Clinique Nantes Atlantis
    Nantes, France     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Prostate Cancer 1464Edap Tms S.a. 3
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.