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Recruiting NCT06276543

Bactiseal Catheter Safety Registry Study

— Observational Hydrocephalus

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: antibiotic-impregnated catheter.
Who it may be relevant to
Registry conditions: Hydrocephalus. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multi-center, Retrospective Registry Study on the Safety of Bactiseal Catheter

Overview

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)

Interventions

  • Device antibiotic-impregnated catheter
    Hydrocephalus patient implant with antibiotic-impregnated catheter to shunt their cerebrospinal fluid.

Primary outcome measures

  • Infection outcome [Time frame: 2 years post catheter implanted.]
  • Safety outcome [Time frame: 2 years post catheter implanted.]

Eligibility criteria

Inclusion criteria

  • The informed consent is exempted by the Ethics Committee of a research center. Or a subject or his/her legal representative signed the informed consent form (ICF) prior to the enrollment.
  • A subject had an indication suitable to use Bactiseal Catheter.
  • A subject implanted hydrocephalus shunt catheter for at least 2 years at the time of enrollment.

Exclusion criteria

  • A subject didn't have an indication suitable to use the catheter.
  • A subject was known to be allergic to a component or ingredient of the catheter to be implanted, including silicone catheter, rifampicin, and clindamycin.
  • According to the comprehensive judgment of an investigator, a subject had an infection of the implant site when the shunt is implanted, such as ventriculitis, meningitis, peritonitis, and local implant skin infection.
  • A subject was simultaneously implanted with another shunt catheter different from Bactiseal Catheter.
  • A subject had a contraindication of the shunt operation.
  • A subject had uncorrected coagulopathy or any bleeding disorder.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 8 centers
  • Xuanwu Hospital, Capital Medical University — Beijing
  • Beijing Hospital — Beijing
  • Zhujiang Hospital of Southern Medical University — Guangzhou
  • the 2nd Affiliated Hospital of Harbin Medical University — Harbin
  • Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology — Wuhan
  • the Zhongnan Hospital of Wuhan University — Wuhan
  • Shanghai Children's Medical Center affiliated to Shanghai Jiaotong University School of Me — Shanghai
  • West China Hospital of Sichuan University — Chengdu

Identifiers

NCT: NCT06276543 · C-BSEAL-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗