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

StatusActive, Not Recruiting
PhaseNot applicable
SponsorInSightec
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Dec 30, 2022 to Dec 30, 2026v11
  2. Primary completion date: Dec 30, 2021 to Dec 30, 2022v10
  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 25 to confirmed 14 · Site details revised at 5 of 5 sitesv9 Show 2 more changesShow less
    • Enrollment target: estimated 25 to confirmed 14
    • Site details revised at 5 of 5 sites
  4. Site contacts updated at 3 of 5 sitesv8
  5. Primary completion date: Jun 30, 2021 to Dec 30, 2021 Completion date: Jun 30, 2022 to Dec 30, 2022 · Site contacts updated at 1 of 5 sitesv7 Show 2 more changesShow less
    • Completion date: Jun 30, 2022 to Dec 30, 2022
    • Site contacts updated at 1 of 5 sites
Show 5 earlier versionsHide 5 earlier versions
  1. Site contacts updated at 1 of 5 sitesv6
  2. Lead sponsor: [Redacted] to InSightec Trial status: Withheld to Recruiting · Primary completion date: Jun 30, 2021 · Completion date: Jun 30, 2022 · 2 morev5 Show 5 more changesShow less
    • Trial status: Withheld to Recruiting
    • Primary completion date: Jun 30, 2021
    • Completion date: Jun 30, 2022
    • Start date: Dec 19, 2019
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  3. 3 versions Re-verified since Aug 5, 2019, no change to tracked fieldsv2-v4
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
InSightec
42 trials monitored
See 1 trial at risk
Prostate Cancer
2,487 trials monitored
See 160 trials at risk
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.
Trial Details
NCT Number NCT03998657
Lead Sponsor InSightec
Conditions Prostate Cancer
Enrollment 14 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov