Evaluation of the TULSA-PRO MRI-Guided Transurethral Ultrasound Prostate Ablation Device in Patients With Localized Prostate Cancer: a Prospective, Single-Arm, Pivotal Clinical Study
What is the purpose of this trial?
A prospective, multi-center, single-arm study, planned in 150 patients. The primary objective of the study is to further evaluate the safety and efficacy of a magnetic resonance imaging (MRI)-guided transurethral ultrasound therapy system (TULSA-PRO) intended to ablate prostate tissue of patients with localized, organ-confined prostate cancer.
- Ages45 years - 80 years
- GenderMale only
- Trial withRadiological Society of North America
- Start Date05/05/2021
- End Date06/30/2023
- Last Updated05/12/2022
- Study HIC#2000029224