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Sonablate HIFU International Registry for PC & BPH Patients

Study acronym: SONAFUSION
StatusRecruiting
PhaseNot specified
SponsorSonablate
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv2
  2. Minor Study First Submitted
2 trials monitored
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2,546 trials monitored
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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.
Trial Details
NCT Number NCT07757490
Lead Sponsor Sonablate
Collaborators: Indiana University
Conditions
(from sponsor)
Localized Prostate Cancer, BPH (Benign Prostatic Hyperplasia), Prostate Cancer; Benign Prostatic Hyperplasia
Related terms Lower Urinary Tract Symptoms, Prostatic Hyperplasia, Prostatic Neoplasms
Enrollment 10,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov