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BeGrow Study to Treat Pulmonary Artery (PA) Stenosis in Newborns and Infants

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 28, 2024 (before its estimated May 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: May 31, 2021 to May 31, 2026
    • Study completion date: May 31, 2024 to May 31, 2027
    • Collaborators shortened, about 3 words
    v5
  2. Primary completion date: Feb 2020 to May 31, 2021v4 Show 5 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 2 to 3
    • Study completion date: Feb 2021 to May 31, 2024
    • Eligibility criteria expanded, about 60 words
    • Collaborator revised
  3. Study sites: 1 to 2v3
  4. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Nov 2017 to Mar 1, 2018
    • Study sites: 0 to 1
    • Primary completion date: Nov 2019 to Feb 2020
    • Study completion date: Nov 2020 to Feb 2021
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Objective of the study is to assess safety and performance of the BeGrow Stent System for newborns and infants in pulmonary artery stenosis.
Trial Details
NCT Number NCT03287024
Lead Sponsor Bentley InnoMed GmbH
Conditions
(from sponsor)		 Pulmonary Artery Stenosis
Related terms Stenosis, Pulmonary Artery
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov