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A Prospective, Randomized, Controlled Trial to Test Safety and Effectiveness of Unilateral Exablate MR-guided Focused Ultrasound Subthalamotomy in Patients With Early-Stage Parkinson's Disease

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

Record History

  1. Trial status changed: Recruiting → Active, Not Recruiting Enrollment target: estimated 72 to confirmed 67 · Site details revised at 4 of 4 sitesv9 Show 2 more changesShow less
    • Enrollment target: estimated 72 to confirmed 67
    • Site details revised at 4 of 4 sites
  2. Secondary endpoints revised (9)v8 See this version in full on ClinicalTrials.gov ↗
  3. Re-verified, no change to tracked fieldsv7
  4. Site details revised at 1 of 4 sitesv6
  5. Study sites: 3 to 4v5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 2 to 3v4
  2. Eligibility criteria shortened, about 11 wordsv3 See this version in full on ClinicalTrials.gov ↗
  3. Study sites: 1 to 2v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
Parkinson's Disease
1,435 trials monitored
See 62 trials at risk
This prospective, randomized, multicenter study aims to evaluate in Early-Stage Parkinson's Disease (ESPD) patients the safety and effectiveness of treatment with Exablate MRgFUS subthalamotomy vs best medical treatment.
Trial Details
NCT Number NCT06584383
Lead Sponsor InSightec
Conditions Parkinson Disease
Enrollment 67 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov