Bactiseal Catheter Safety Registry Study

Last updated: January 23, 2025
Sponsor: Integra LifeSciences Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

antibiotic-impregnated catheter

Clinical Study ID

NCT06276543
C-BSEAL-002
  • All Genders

Study Summary

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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The informed consent is exempted by the Ethics Committee of a research center. Or asubject or his/her legal representative signed the informed consent form (ICF) priorto the enrollment.

  2. A subject had an indication suitable to use Bactiseal Catheter.

  3. A subject implanted hydrocephalus shunt catheter for at least 2 years at the time ofenrollment.

Exclusion

Exclusion Criteria:

  1. A subject didn't have an indication suitable to use the catheter.

  2. A subject was known to be allergic to a component or ingredient of the catheter tobe implanted, including silicone catheter, rifampicin, and clindamycin.

  3. According to the comprehensive judgment of an investigator, a subject had aninfection of the implant site when the shunt is implanted, such as ventriculitis,meningitis, peritonitis, and local implant skin infection.

  4. A subject was simultaneously implanted with another shunt catheter different fromBactiseal Catheter.

  5. A subject had a contraindication of the shunt operation.

  6. A subject had uncorrected coagulopathy or any bleeding disorder.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: antibiotic-impregnated catheter
Phase:
Study Start date:
September 29, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Beijing Children's Hospital, Capital Medical University

    Beijing, Beijing 100045
    China

    Site Not Available

  • Beijing Hospital

    Beijing, Beijing 100730
    China

    Completed

  • Xuanwu Hospital, Capital Medical University

    Beijing, Beijing 100053
    China

    Completed

  • Guangdong Province People Hospital

    Guangzhou, Guangdong 519041
    China

    Site Not Available

  • Guangzhou Women and Children Medical Center

    Guangzhou, Guangdong 510623
    China

    Site Not Available

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong 510280
    China

    Completed

  • the 2nd Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang
    China

    Active - Recruiting

  • Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei 430030
    China

    Completed

  • the Zhongnan Hospital of Wuhan University

    Wuhan, Hubei 430071
    China

    Active - Recruiting

  • Shanghai Children's Medical Center affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai 200127
    China

    Active - Recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

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