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Bactiseal Catheter Safety Registry Study

StatusRecruiting
PhaseNot specified
Started
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Record status
This record was last updated January 27, 2025 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 1, 2024 to Sep 29, 2024
    • Study sites revised (8)
    v4
  2. Notable Start date: Jun 1, 2024 to Sep 1, 2024v3
  3. Notable Start date: Apr 1, 2024 to Jun 1, 2024v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Research Purpose: This study aims to continuously evaluate the safety of subjects implanted with a catheter (trade name: Bactiseal) produced by Integra LifeSciences Production Corporation. Device safety will be assessed based on all the adverse events that occurred within 2 years after implanted the catheter. Research Design: This study is designed to be single arm, multi-center, and retrospective. A total of 200 subjects will be retrospectively enrolled. Information will be collected on adverse events, including bacterial culture and drug resistance testing when infection (if done), of subjects enrolled within 2 years after the implantation of the Bactiseal Catheter between January 01, 2019 and June 30, 2022. The following information will be collected from subjects' medical records or hospitals' databases (if any): 1. General condition of the subjects (including previous shunting and external drainage operation) 2. Intraoperative condition and catheter implantation 3. Information on the shunt catheters 4. Adverse events of subjects within 2 years after the operation and classification of the adverse events (except anticipated adverse events listed in section 8.1.2) 5. Relevant examinations in case of postoperative infection, including bacterial culture and drug resistance testing (if done)
Trial Details
NCT Number NCT06276543
Lead Sponsor Integra LifeSciences Corporation
Conditions
(from sponsor)
Hydrocephalus
Related terms Hydrocephalus, Infections
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov