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Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 158 to confirmed 160
    • Site details revised at 9 of 9 sites
    v10
  2. Notable Primary completion date: Aug 31, 2027 to Jan 24, 2029
    • Study completion date: Sep 30, 2027 to Jan 24, 2029
    • Site details revised at 1 of 9 sites
    v9
  3. Minor Site details revised at 3 of 9 sitesv8
  4. Notable Primary endpoint revised
    • Study sites: 6 to 9
    v7
  5. Notable Enrollment target: 258 to 158v6 Show 5 more changesShow less
    • Primary endpoints: 3 to 1
    • Study sites: 4 to 6
    • Primary completion date: Mar 31, 2027 to Aug 31, 2027
    • Study completion date: Apr 30, 2027 to Sep 30, 2027
    • Eligibility criteria expanded, about 25 words
Show 4 earlier versionsHide 4 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv5
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 1, 2023 to Jan 24, 2023
    • Site details revised at 4 of 4 sites
    v4
  3. Minor Eligibility criteria shortened, about 3 wordsv3
  4. Notable Start date: Jul 30, 2022 to Dec 1, 2023
    • Primary endpoints revised (3)
    • Study title expanded, about 3 words
    v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.
Trial Details
NCT Number NCT05397106
Lead Sponsor Integra LifeSciences Corporation
Conditions
(from sponsor)
Hydrocephalus, Hydrocephalus in Children, NPH (Normal Pressure Hydrocephalus), IIH - Idiopathic Intracranial Hypertension, Brain Tumor, Post-Traumatic Hydrocephalus, Hemorrhagic Stroke
Related terms Brain Neoplasms, Hemorrhagic Stroke, Hydrocephalus, Hydrocephalus, Normal Pressure, Pseudotumor Cerebri
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov