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Clinical Trial Details

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Brief Title Pivotal Study of MRI-guided Transurethral Ultrasound Ablation in Patients With Localized Prostate Cancer
Official Title 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
Principal Investigator Oto, Aytekin
Brief Summary A prospective, multi-center, single-arm study, planned in 110 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.
Gender Male
Ages 45 Years
Enrollment 110
Accepts Healthy Volunteers No
Lead Sponsor Profound Medical Inc.Other
Collaborator
Study Design
Study Phase Phase 2
Study Type Interventional
Contact Name Steve Raman, MD
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Prostate Cancer
Detail for Health Professional (on clinicaltrials.gov)
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