Clinical Data Collection of Patients Treated With High Intensity Focused Ultrasound (HIFU) by the… (NCT07645872) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Data Collection of Patients Treated With High Intensity Focused Ultrasound (HIFU) by the Focal One for Their Prostate Cancer.
France3,000 participantsStarted 2023-02-01
Plain-language 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.
Who can participate
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is focused on monitoring safety data rather than testing a new treatment, what does that mean for understanding the risks of the Focal One HIFU procedure — and what side effects should I know about going in?
2How does HIFU with the Focal One compare to standard treatments like surgery or radiation for my specific type and stage of prostate cancer, and is joining this data collection study the right path before considering those options?
3This study is described as data collection rather than a traditional clinical trial phase — does that mean the HIFU procedure itself is already approved and in use, and what would my treatment experience look like compared to a patient not in the study?
4What kinds of follow-up visits or monitoring would I need to participate in this study, and how would that fit into my existing care schedule?
5If I join this trial and experience a complication or the HIFU treatment doesn't fully control my cancer, what are the next steps or backup treatment options available to me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To monitor the safety of HIFU treatment with the Focal One in patients treated for prostate cancer.
Timeframe: From HIFU treatment up to 5 years post-HIFU