Sonablate HIFU International Registry for PC & BPH Patients

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Sonablate
Study ID
NCT07757490
Status
Recruiting
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Conditions

  • BPH (Benign Prostatic Hyperplasia)
  • Localized Prostate Cancer
  • Prostate Cancer; Benign Prostatic Hyperplasia

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • High Intensity Focused Ultrasound — DEVICE
    Use of high intensity focused utrasound and sonatripsy for thermal and mechanical tissue ablation

Study Details

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.

Key Dates

First listed
Aug 11, 2026
Start date
Jan 1, 2015
Status verified
Aug 2026
Primary completion
Dec 31, 2035
Completion
Dec 31, 2035

Study Design

Enrollment
10,000 participants (estimated)

Arms

  • Arm: Retrospective Cohort
    Historical, fully de-identified clinical data from patients treated for localized prostate cancer or BPH who underwent Sonablate HIFU ablation as part of standard clinical care.
  • Arm: Prospective Cohort
    Newly treated prostate cancer or BPH patients undergoing Sonablate HIFU ablation as part of standard clinical care, subject to a mandatory 180-day post-procedure data abstraction delay.

Primary Outcome Measure

Biochemical and Histological Recurrence-Free Survival Rate [ Time Frame: Baseline, and annually up to 10 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana University Medical CenterIndianapolisIndiana46202
Clint D. Bahler, MD
[email protected]
317-944-3458

Find similar trials in Indianapolis, IN

By research site
Indiana University Medical Center· Indianapolis, IN

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