Bactiseal Catheter Safety Registry Study

Официальное название

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

Обзор

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)

Вмешательства

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

Первичные конечные точки

• Infection outcome [Срок оценки: 2 years post catheter implanted.]
• Safety outcome [Срок оценки: 2 years post catheter implanted.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 8 центров

• Xuanwu Hospital, Capital Medical University — Пекин
• Beijing Hospital — Пекин
• Zhujiang Hospital of Southern Medical University — Гуанчжоу
• the 2nd Affiliated Hospital of Harbin Medical University — Харбин
• Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology — Ухань
• the Zhongnan Hospital of Wuhan University — Ухань
• Shanghai Children's Medical Center affiliated to Shanghai Jiaotong University School of Me — Шанхай
• West China Hospital of Sichuan University — Чэнду

Идентификаторы

NCT: NCT06276543 · C-BSEAL-002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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