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ExAblate Pallidotomy for Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Parkinson's Disease

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

Record History

  1. Re-verified, no change to tracked fieldsv28
  2. Primary completion date changed from estimate of Jan 31, 2025 to Jul 25, 2024 Completion date: Jan 31, 2025 to Aug 31, 2026v27 Show 1 more changeShow less
    • Completion date: Jan 31, 2025 to Aug 31, 2026
  3. Primary completion date: Jan 31, 2021 to Jan 31, 2025v26
  4. Re-verified, no change to tracked fieldsv25
  5. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 107 to confirmed 92 · Site details revised at 20 of 20 sitesv24 Show 2 more changesShow less
    • Enrollment target: estimated 107 to confirmed 92
    • Site details revised at 20 of 20 sites
Show 22 earlier versionsHide 22 earlier versions
  1. Enrollment target: 92 to 107 Study sites: 19 to 20v23 Show 1 more changeShow less
    • Study sites: 19 to 20
  2. Primary completion date: Dec 31, 2019 to Jan 31, 2021 Completion date: Dec 31, 2020 to Jan 31, 2025v22 Show 1 more changeShow less
    • Completion date: Dec 31, 2020 to Jan 31, 2025
  3. Study sites: 18 to 19v21
  4. Study sites: 17 to 18v20
  5. Study sites: 15 to 17v19
  6. Site contacts updated at 2 of 15 sitesv18
  7. Primary endpoint revised Enrollment target: 116 to 92 · Study sites revised (15) · Eligibility criteria expanded, about 1 wordv17 Show 3 more changesShow less
    • Enrollment target: 116 to 92
    • Study sites revised (15)
    • Eligibility criteria expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  8. Study sites: 13 to 15v16
  9. Study sites: 12 to 13v15
  10. Study sites: 11 to 12v14
  11. Study sites: 9 to 11 Study title shortened, about 7 wordsv13 Show 1 more changeShow less
    • Study title shortened, about 7 words

    See this version in full on ClinicalTrials.gov ↗

  12. Study sites: 8 to 9v12
  13. Re-verified, no change to tracked fieldsv11
  14. Site details revised at 2 of 8 sitesv10
  15. Study sites: 7 to 8v9
  16. Study sites: 6 to 7v8
  17. Study sites: 5 to 6v7
  18. Study sites: 4 to 5v6
  19. Study sites: 3 to 4v5
  20. Site details revised at 1 of 3 sitesv4
  21. Re-verified, no change to tracked fieldsv3
  22. Trial status: Not Yet Recruiting to Recruiting Start date: Jan 1, 2018 to Feb 9, 2018 · Study sites: 1 to 3v2 Show 2 more changesShow less
    • Start date: Jan 1, 2018 to Feb 9, 2018
    • Study sites: 1 to 3
  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
Evaluate the safety and efficacy of unilateral focused ultrasound pallidotomy using the ExAblate 4000 System in the management of dyskinesia symptoms or motor fluctuations for medication refractory, advanced idiopathic Parkinson's disease.
Trial Details
NCT Number NCT03319485
Lead Sponsor InSightec
Conditions Parkinson Disease
Enrollment 92 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov