Sonablate HIFU International Registry for PC & BPH Patients

Traditional surgical interventions for prostate cancer and benign prostatic hyperplasia (BPH) are often associated with significant morbidity. While high-intensity focused ultrasound (HIFU) has emerged as a recognized, minimally invasive alternative, existing clinical evidence often lacks prospective, long-term follow-up and standardized, validated outcome assessments. To systematically track and evaluate these standard-of-care interventions, the SONA FUSION Registry serves as a central repository for the consolidation of real-world clinical data from leading academic and clinical centers globally. The registry is designed to refine HIFU treatment protocols, improve patient counseling practices, and establish evidence-based scientific foundations for the standardized adoption of robotic HIFU technology. The central repository at Indiana University receives and maintains exclusively de-identified research data. The protocol structurally prevents re-identification by mandating the permanent removal of all direct identifiers at the local site level prior to transmission. Furthermore, clinical dates are strictly protected via temporal masking, converting all temporal data to relative study days-and a non-negotiable 180-day post-procedure delay is enforced before any prospective data is authorized for abstraction. To continuously validate these safeguards, an independent Honest Broker conducts an annual audit of a 20 percent sample of the database, ensuring the central research team remains definitively blinded to all patient identifiers.