Clinical trial · Observational
Clinical Data Collection of Patients Treated With High Intensity Focused Ultrasound (HIFU) by the Focal One for Their Prostate Cancer.
NCT07645872CI-TRIAL-00114548One registryrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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
- description
- Safety will be assessed by collecting adverse events related to HIFU treatment.
Secondary outcomes (4)
- measure
- PSA values after HIFU treatment
- timeFrame
- From HIFU treatment up to 5 years post-HIFU
- description
- 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.
- measure
- Incidence of local recurrence detected by prostate MRI after HIFU treatment
- timeFrame
- From HIFU treatment up to 5 years post-HIFU
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.