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

About This Trial

  • This study is collecting real-world health information to see how safe and effective a sound-wave treatment using the Focal One device is for prostate cancer.
  • It is designed for patients who are already planning to receive or are receiving treatment with this specific machine.
  • Because this is an observational study, you will not receive any experimental treatments or extra medical procedures.
  • Before deciding to participate, you should know that joining simply means giving permission for researchers to review your medical records to help improve care for future patients.

More Information

  • 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 Enroll

  • Gender: Male
  • Who This Trial is For: This study is collecting real-world health information to see how safe and effective a sound-wave treatment using the Focal One device is for prostate cancer.

Study Details

  • Start Date: February 1, 2023
  • Lead Sponsor: EDAP TMS S.A.
Full Eligibility 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
View Trial Locations and Contact Information (opens in new tab)