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Bactiseal Catheter Safety Registry Study

Recruitingn/aAges any - anyAllIntegra LifeSciences Corporation
NCT06276543 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. 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. 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 of enrollment. 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 to be implanted, including silicone catheter, rifampicin, and clindamycin. 3. 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. 4. A subject was simultaneously implanted with another shunt catheter different from Bactiseal Catheter. 5. A subject had a contraindication of the shunt operation. 6. A subject had uncorrected coagulopathy or any bleeding disorder.
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What it tests

  • antibiotic-impregnated catheter
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Where

8 sites
Xuanwu Hospital, Capital Medical University
Beijing, China
Beijing Hospital
Beijing, China
Zhujiang Hospital of Southern Medical University
Guangzhou, China
the 2nd Affiliated Hospital of Harbin Medical University
Harbin, China
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
the Zhongnan Hospital of Wuhan University
Wuhan, China
Shanghai Children's Medical Center affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, China
West China Hospital of Sichuan University
Chengdu, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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