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NCT03998657 · ClinicalTrials.gov record · last posted 2025-05-01

Continued Access of Focal MR-Guided Focused Ultrasound for Localized Intermediate Risk Prostate Lesions

StatusActive, Not Recruiting
PhaseNot applicable
SponsorInSightec
Started2019-12-19
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
This extended clinical investigation is a multicenter, prospective, single arm study intended to provide continued access of the Exablate Model 2100 device (Exablate Prostate) to patients for treatment of prostate lesions and collect additional safety and effectiveness data during the 510(k) preparation and review period.

Amendment record 10 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 10 times since 2019-06-24; most recent amendment 2025-04-30. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2020-12-17
Status change Recruiting→Active, Not Recruitingv8
2020-01-23
Status change Withheld→Recruitingv4
Trial Details
NCT Number NCT03998657
Lead Sponsor InSightec
Conditions Prostate Cancer
Enrollment 14 participants
Start Date 2019-12-19
Primary Completion 2026-12-30 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-05-01