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

June 10, 2026 updated by: EDAP TMS S.A.
The aim of the registry is to gather real-life data to evaluate the clinical performance and safety of medical devices in patients who have been treated with HIFU thank to the Focal One device for their prostate cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

It is a prospective and retrospective register.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Aix-en-Provence, France, 13080
        • Recruiting
        • Hôpital privé Aix en provence
        • Contact:
        • Principal Investigator:
          • David BARRIOL, Dr
      • Besançon, France, 25056
        • Recruiting
        • Clinique Saint vincent
        • Contact:
        • Principal Investigator:
          • Vincent BAILLY, Dr
      • Colmar, France, 68000
        • Recruiting
        • Hôpital Civil Colmar
        • Contact:
        • Principal Investigator:
          • Santiago LOPEZ, dr
      • Lyon, France, 69000
        • Recruiting
        • Hôpital Edouard Heriot
        • Principal Investigator:
          • Sébastien CROUZET, Pr
        • Contact:
      • Nantes, France, 44000
        • Recruiting
        • Clinique Nantes Atlantis
        • Contact:
        • Principal Investigator:
          • Eric POTIRON, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients Being treated for prostate cancer with the Focal One device

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To monitor the safety of HIFU treatment with the Focal One in patients treated for prostate cancer.
Time Frame: From HIFU treatment up to 5 years post-HIFU
Safety will be assessed by collecting adverse events related to HIFU treatment.
From HIFU treatment up to 5 years post-HIFU

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PSA values after HIFU treatment
Time Frame: From HIFU treatment up to 5 years post-HIFU
Oncological outcomes will be assessed using PSA measurements obtained as part of routine care. The outcome will be reported as PSA values measured during follow-up after HIFU treatment.
From HIFU treatment up to 5 years post-HIFU
Incidence of local recurrence detected by prostate MRI after HIFU treatment
Time Frame: From HIFU treatment up to 5 years post-HIFU
Local recurrence will be assessed using prostate MRI performed as part of routine care. The outcome will be reported as the number and proportion of patients with imaging findings suspicious for local recurrence.
From HIFU treatment up to 5 years post-HIFU
Prostate biopsy results after HIFU treatment
Time Frame: From HIFU treatment up to 5 years post-HIFU
Oncological outcomes will be assessed using prostate biopsy results obtained as part of routine care. The outcome will be reported as the number and proportion of patients with positive biopsy findings during follow-up after HIFU treatment.
From HIFU treatment up to 5 years post-HIFU
To estimate the retreatment rate of patients treated with HIFU
Time Frame: From HIFU treatment up to 5 years post-HIFU
The rate and timing of retreatment (radical prostatectomy, radiotherapy, cryotherapy, HIFU, other focal treatment) after HIFU treatment will be assessed using data from the patient's clinical follow-up.
From HIFU treatment up to 5 years post-HIFU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
EDAP TMS S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HIFU/EU/22.02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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