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A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Thalamotomy for the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease

StatusRecruiting
PhaseNot specified
SponsorInSightec
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site contacts updated at 1 of 8 sitesv6
  2. Study sites: 2 to 8v5
  3. Site contacts updated at 1 of 2 sitesv4
  4. Study sites: 1 to 2v3
  5. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Sep 2021 to Apr 28, 2022 · Study sites: 0 to 1 · Primary completion date: Sep 2027 to Dec 2027 · 1 morev2 Show 4 more changesShow less
    • Start date changed from estimate of Sep 2021 to Apr 28, 2022
    • Study sites: 0 to 1
    • Primary completion date: Sep 2027 to Dec 2027
    • Study description shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
The objectives of this study are to collect the long-term safety and effectiveness data of performing thalamotomy for tremor dominant Parkinson's Disease (TDPD) using the Exablate Neuro system.
Trial Details
NCT Number NCT04991831
Lead Sponsor InSightec
Conditions Tremor Associated With Tremor Dominant Parkinson's Disease
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov