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PHIL® Embolic System Pediatric IDE

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv10
  2. Site contact updatedv9
  3. Site contact updatedv8
  4. Primary and study completion dates: Dec 2023 to Dec 2027
    • Site contact updated
    v7
  5. Primary and study completion dates: Dec 2022 to Dec 2023
    • Site contact updated
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. 2 versions Re-verified since Apr 28, 2020, no change to tracked fieldsv4-v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2019 to Apr 16, 2019
    • Site details revised
    v3
  3. Start date: Dec 2018 to May 2019v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to collect information about how the PHIL® Embolic System works in the treatment of intracranial dural arteriovenous fistulas. Data collected in this study will be used to evaluate the safety and probable benefits in treating DAVFs. The PHIL® Embolic System is a Humanitarian Use Device (HUD). The U.S. Food and Drug Administration (FDA) approved the use of the PHIL Embolic System as a HUD in June 2016.
Trial Details
NCT Number NCT03731000
Lead Sponsor Alejandro Berenstein
Conditions
(from sponsor)		 Arterio-venous Fistula, Intracranial Arteriovenous Malformations
Related terms Arteriovenous Fistula, Intracranial Arteriovenous Malformations
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov