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Fetal Treatment of Galenic Malformations

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Results first posted: Jan 6, 2026
    • Enrollment target: estimated 25 to confirmed 7
    • Secondary endpoint revised
    • Primary endpoint revised
    v15
  2. Primary completion date changed from estimate of Dec 2025 to Sep 6, 2024
    • Study completion date: Dec 2027 to Aug 2026
    v14
  3. Trial status: Suspended to Active, Not Recruitingv13
  4. Trial status: Recruiting to Suspended Sponsor's reason: Pending interim review
    • Site details revised
    v12
  5. Enrollment target: 20 to 25
    • Eligibility criteria revised
    v11
Show 9 earlier versionsHide 9 earlier versions
  1. Primary completion date: Dec 2023 to Dec 2025
    • Study completion date: Dec 2025 to Dec 2027
    • Eligibility criteria expanded, about 3 words
    v10
  2. Start date changed from estimate of Sep 2022 to Sep 30, 2022v9
  3. Start date: Dec 2021 to Sep 2022v8
  4. Start date: Jun 2021 to Dec 2021
    • Primary completion date: Aug 2023 to Dec 2023
    • Study completion date: Aug 2025 to Dec 2025
    v7
  5. Start date: Feb 2021 to Jun 2021v6
  6. Start date: Dec 2020 to Feb 2021v5
  7. Start date: Oct 2020 to Dec 2020v4
  8. Start date: Aug 2020 to Oct 2020v3
  9. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Jul 2023 to Aug 2023
    • Study completion date: Jul 2025 to Aug 2025
    • Start date: Jul 2020 to Aug 2020
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a prospective, single-arm non-randomized interventional study of fetuses to assess the safety and efficacy of fetal embolization of Vein of Galen Malformation (VOGM). Subjects will receive a one-time study intervention of fetal embolization. Follow-up assessments will be collected every 4 weeks until delivery, as per standard of care. After delivery, neurological assessments will be performed every 6 months for 2 years (adjusted for gestational age). Data will be compared to historical cohorts.
Trial Details
NCT Number NCT04434729
Lead Sponsor Darren Orbach
Conditions
(from sponsor)		 Vein of Galen Malformations
Related terms Vein of Galen Malformations
Enrollment 7 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov