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NCT Number: NCT06276543

Bactiseal Catheter Safety Registry Study

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)

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Key information

Conditions

Hydrocephalus Brain Diseases Central Nervous System Diseases Infections Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

antibiotic-impregnated catheter

Device

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

Primary outcomes

  1. Infection outcome

    Time frame: 2 years post catheter implanted.

    Incidence of Bactiseal Shunt catheter related infection within 2 years post implant.

  2. Safety outcome

    Time frame: 2 years post catheter implanted.

    Incidence of adverse events of a subject within 2 years post implant Bactiseal

Study contacts

Contact information is provided by the study sponsor or research team.

Hua Tang, MD

CONTACT

[email protected]

0086 21-63179772 ext. 8108

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 26, 2024
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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