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Patch vs. No Patch Fetoscopic Meningomyelocele Repair Study

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 3 months later Aug 2026 → Dec 2027
See other at-risk trials from Baylor College of Medicine

Record History

  1. Primary and study completion pushed from Aug 2026 to Dec 2027 Primary endpoints: details revised at 1 of 1 entry · Eligibility criteria expanded, about 29 words · Site details revised at 1 of 2 sites · 2 more Show 5 more changesShow less
    • Primary endpoints: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 29 words
    • Site details revised at 1 of 2 sites
    • Publications: details revised at 2 of 2 entries
    • Study description expanded, about 2 words
  2. 2 versions Re-verified since Feb 17, 2025, no change to tracked fieldsv11-v12
  3. Primary completion date: Aug 2024 to Aug 2026v10
  4. 2 versions Re-verified since Apr 2, 2022, no change to tracked fieldsv8-v9
  5. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 60 to confirmed 38 · Primary completion date: Dec 2024 to Aug 2024 · Completion date: Dec 2025 to Aug 2026 · 1 morev7 Show 4 more changesShow less
    • Enrollment target: estimated 60 to confirmed 38
    • Primary completion date: Dec 2024 to Aug 2024
    • Completion date: Dec 2025 to Aug 2026
    • Site details revised at 2 of 2 sites
Show 5 earlier versionsHide 5 earlier versions
  1. 2 versions Re-verified since Jul 1, 2020, no change to tracked fieldsv5-v6
  2. Eligibility criteria expanded, about 91 words Study description expanded, about 371 wordsv4 Show 1 more changeShow less
    • Study description expanded, about 371 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 1 to 2v3
  4. Eligibility criteria expanded, about 3 wordsv2 See this version in full on ClinicalTrials.gov ↗
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 the study is to compare the maternal, fetal and neonatal outcomes of a cohort of 60 patients in whom a multilayer closure with a Durepair patch is performed with a prior cohort of patients in whom a standardized repair without patch (n = 32) was performed using the same minimally invasive fetoscopic repair technique. The hypothesis is that there will be a thicker repair (as measured by MRI at 6 weeks post surgery) and less MMC repair dehiscence and/or CSF leak with the patch repair.
Trial Details
NCT Number NCT03794011
Lead Sponsor Baylor College of Medicine
Conditions Neural Tube Defects
Enrollment 38 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov