HIFU for Focal Ablation of Prostate Tissue: An Observational Study
NCT03620786 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100
Last updated 2026-04-16
Summary
The Sonablate HIFU device was approved by the U.S.FDA for prostate tissue ablation in October, 2015. The purpose of this observational research study is to investigate the localized treatment of prostate cancer using HIFU through clinical data and health-related quality of life (HRQOL) questionnaires.
Conditions
Interventions
- DEVICE
-
Sonablate HIFU device
In this study, we will be using the Sonablate 450 HIFU System. The Sonablate HIFU device was approved by the U.S. FDA for prostate tissue ablation in October, 2015. HIFU is an example of focal therapy, where the intervention involves targeting diseased areas of prostate tissue, while preserving healthy prostate tissue and minimizing damage to surrounding structures.
Sponsors & Collaborators
-
University of California, Los Angeles
lead OTHER
Principal Investigators
-
Leonard Marks, MD · University of California, Los Angeles
Eligibility
- Min Age
- 40 Years
- Max Age
- 85 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-09-26
- Primary Completion
- 2027-01-31
- Completion
- 2028-01-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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