Evaluating the safety of Bactiseal Catheters in hydrocephalus patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the safety of the Bactiseal catheter, an antibiotic-impregnated device used for hydrocephalus management. It will retrospectively enroll 200 subjects who had the catheter implanted between January 1, 2019, and June 30, 2022, collecting data on adverse events and infections over a two-year period. Information will be gathered from medical records regarding the subjects' general condition, intraoperative details, and any complications encountered. The study is designed to provide insights into the effectiveness and safety of this catheter in preventing infections.

Why it matters

Who can join: the full rules

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.

Where it's running

• the 2nd Affiliated Hospital of Harbin Medical University
  Harbin, Heilongjiang, China Recruiting
• the Zhongnan Hospital of Wuhan University
  Wuhan, Hubei, China Recruiting
• Shanghai Children's Medical Center affiliated to Shanghai Jiaotong University School of Medicine
  Shanghai, Shanghai Municipality, China Recruiting
• West China Hospital of Sichuan University
  Chengdu, Sichuan, China Recruiting
• Xuanwu Hospital, Capital Medical University
  Beijing, Beijing Municipality, China Completed
• Beijing Hospital
  Beijing, Beijing Municipality, China Completed

Study contacts

• Principal investigator: Nan Bao, MD — Shanghai Children's Medical Center Affiliated to Shanghai Jiaotong University School of Medicine
• Study coordinator: Hua Tang, MD
• Email: hua.tang@integralife.com
• Phone: 0086 21-63179772

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Evaluating a device for measuring cerebrospinal fluid flow and headaches

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.