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RECRUITING
NCT07757490

Sonablate HIFU International Registry for PC & BPH Patients

Sponsor: Sonablate

View on ClinicalTrials.gov

Summary

The SONA FUSION Registry is an observational study designed to evaluate the long-term effectiveness and safety of the Sonablate High-Intensity Focused Ultrasound (HIFU) system. This study focuses on adult men who have been treated for localized prostate cancer, benign prostatic hyperplasia (BPH) with urinary symptoms, or a combination of both conditions. The registry collects real-world medical data from multiple clinics globally to better understand how well the HIFU treatment controls disease and affects urinary and sexual function over a 10- to 20-year period. The study includes two groups of participants: a retrospective group of patients who previously received treatment, and a prospective group of newly treated patients receiving standard clinical care. No experimental interventions are assigned for the purpose of this study. To protect participant privacy, all medical data is completely de-identified and stripped of direct identifiers before being securely transferred to the central coordinating center at Indiana University. The ultimate goal of this research is to improve patient care protocols, advance men's health knowledge, and establish evidence-based guidelines for minimally invasive prostate treatments.

Official title: SONA FUSION Registry (Long-term Evaluation of Sonablate High-Intensity Focused Ultrasound for the Treatment of Prostate Cancer and Benign Prostatic Hyperplasia)

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

10000

Start Date

2015-01-01

Completion Date

2035-12

Last Updated

2026-08-11

Healthy Volunteers

No

Interventions

DEVICE

High Intensity Focused Ultrasound

Use of high intensity focused utrasound and sonatripsy for thermal and mechanical tissue ablation

Locations (1)

Indiana University Medical Center

Indianapolis, Indiana, United States