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A Feasibility Safety Study of Benign Centrally-Located Intracranial Tumors in Pediatric and Young Adult Subjects

StatusRecruiting
PhaseNot applicable
SponsorInSightec
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site contacts updated at 1 of 3 sitesv23
  2. Study sites: 2 to 3v22
  3. Study sites revised (2)v21 See this version in full on ClinicalTrials.gov ↗
  4. Re-verified, no change to tracked fieldsv20
  5. Enrollment target: 10 to 20 Primary and study completion dates: Dec 31, 2024 to Dec 31, 2026 · Eligibility criteria expanded, about 249 wordsv19 Show 2 more changesShow less
    • Primary and study completion dates: Dec 31, 2024 to Dec 31, 2026
    • Eligibility criteria expanded, about 249 words

    See this version in full on ClinicalTrials.gov ↗

Show 17 earlier versionsHide 17 earlier versions
  1. Primary completion date: Dec 31, 2022 to Dec 31, 2024 Completion date: Dec 31, 2023 to Dec 31, 2024v18 Show 1 more changeShow less
    • Completion date: Dec 31, 2023 to Dec 31, 2024
  2. Study sites: 1 to 2v17
  3. Re-verified, no change to tracked fieldsv16
  4. Site contact updatedv15
  5. Study site revisedv14 See this version in full on ClinicalTrials.gov ↗
  6. Site contact updatedv13
  7. Primary completion date: Mar 31, 2021 to Dec 31, 2022 Completion date: Dec 31, 2022 to Dec 31, 2023v12 Show 1 more changeShow less
    • Completion date: Dec 31, 2022 to Dec 31, 2023
  8. Primary completion date: Mar 31, 2020 to Mar 31, 2021 Completion date: Dec 31, 2021 to Dec 31, 2022v11 Show 1 more changeShow less
    • Completion date: Dec 31, 2021 to Dec 31, 2022
  9. Eligibility criteria shortened, about 575 wordsv10 See this version in full on ClinicalTrials.gov ↗
  10. Site contact updatedv9
  11. Start date: Jan 12, 2017 to Feb 28, 2017v8
  12. Site contact updatedv7
  13. Primary completion date: Jan 15, 2019 to Mar 31, 2020 Completion date: Jan 15, 2019 to Dec 31, 2021v6 Show 1 more changeShow less
    • Completion date: Jan 15, 2019 to Dec 31, 2021
  14. 2 versions Re-verified since Dec 21, 2017, no change to tracked fieldsv4-v5
  15. Site contact updatedv3
  16. Site contact updatedv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
The goal of this prospective, non-randomized, single-arm, feasibility study is to develop data to evaluate the safety and feasibility of ExAblate 4000 treatment of benign intracranial tumors which require clinical intervention in pediatric and young adult subjects. Indication of Use: Ablation of benign intracranial tumors in children and young adults which are ExAblate accessible.
Trial Details
NCT Number NCT03028246
Lead Sponsor InSightec
Conditions Benign Centrally-Located Intracranial Tumors
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov