Clinical Data Collection of Patients Treated With High Intensity Focused Ultrasound (HIFU) by the Focal One for Their Prostate Cancer.
One registry
1 other identifier
observational
3,000
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2023
Longer than P75 for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2023
CompletedFirst Submitted
Initial submission to the registry
March 5, 2026
CompletedFirst Posted
Study publicly available on registry
June 12, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2031
June 12, 2026
June 1, 2026
8.2 years
March 5, 2026
June 10, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
To monitor the safety of HIFU treatment with the Focal One in patients treated for prostate cancer.
Safety will be assessed by collecting adverse events related to HIFU treatment.
From HIFU treatment up to 5 years post-HIFU
Secondary Outcomes (4)
PSA values after HIFU treatment
From HIFU treatment up to 5 years post-HIFU
Incidence of local recurrence detected by prostate MRI after HIFU treatment
From HIFU treatment up to 5 years post-HIFU
Prostate biopsy results after HIFU treatment
From HIFU treatment up to 5 years post-HIFU
To estimate the retreatment rate of patients treated with HIFU
From HIFU treatment up to 5 years post-HIFU
Eligibility Criteria
Patients Being treated for prostate cancer with the Focal One device
You may qualify if:
- 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
You may not qualify if:
- Patient deprived of liberty following a judicial or administrative decision
- Patient under guardianship or curatorship \* if applicable according to local regulation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EDAP TMS S.A.lead
Study Sites (5)
Hôpital privé Aix en provence
Aix-en-Provence, 13080, France
Clinique Saint vincent
Besançon, 25056, France
Hôpital Civil Colmar
Colmar, 68000, France
Hôpital Edouard Heriot
Lyon, 69000, France
Clinique Nantes Atlantis
Nantes, 44000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Target Duration
- 5 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2026
First Posted
June 12, 2026
Study Start
February 1, 2023
Primary Completion (Estimated)
April 1, 2031
Study Completion (Estimated)
April 1, 2031
Last Updated
June 12, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share