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Sonablate HIFU International Registry for PC & BPH Patients

NCT07757490 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 10000

Last updated 2026-08-11

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

High Intensity Focused Ultrasound

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

Sponsors & Collaborators

  • Indiana University

    collaborator OTHER

  • Sonablate

    lead INDUSTRY

Principal Investigators

  • Clint D. Bahler, MD, MS · Indiana University Medical Center

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-01
Primary Completion
2035-12-31
Completion
2035-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07757490 on ClinicalTrials.gov