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SEAL™IT: Saccular Endovascular Aneurysm Lattice System Interventional Pivotal Trial

Study acronym: SEAL™IT
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 16, 2026 (before its estimated September 10, 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 6 of 6 sites
    v10
  2. Study sites: 5 to 6v9
  3. Study sites: 4 to 5v8
  4. Phase: Not applicable to Phase 3
    • Study sites: 1 to 4
    v7
  5. Trial status: Not Yet Recruiting to Recruiting
    • Enrollment target: 170 to 279
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 15, 2024 to Aug 6, 2024
    v6
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  1. Re-verified, no change to tracked fieldsv5
  2. Phase: Phase 3 to Not applicablev4 Show 7 more changesShow less
    • Start date: Sep 1, 2023 to Jul 15, 2024
    • Enrollment target: 140 to 170
    • Primary completion date: Sep 1, 2026 to Sep 10, 2026
    • Study completion date: Sep 1, 2030 to Sep 10, 2030
    • Eligibility criteria expanded, about 125 words
    • Study description expanded, about 10 words
    • Study arms: 0 to 1
  3. Primary endpoint revisedv3
  4. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
To establish the safety and effectiveness of the SEAL™ Saccular Endovascular Aneurysm Lattice system for the treatment of saccular intracranial aneurysms. The data from this study will be used to support a premarket approval (PMA) submission.
Trial Details
NCT Number NCT05831202
Lead Sponsor Galaxy Therapeutics INC
Conditions
(from sponsor)		 Intracranial Aneurysm
Related terms Intracranial Aneurysm
Enrollment 279 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov