Bactiseal Catheter Safety Registry Study

Launched by INTEGRA LIFESCIENCES CORPORATION · Feb 21, 2024

Keywords

ClinConnect Summary

The Bactiseal Catheter Safety Registry Study is researching the safety of a specific type of catheter called the Bactiseal, which is used to treat hydrocephalus—a condition where fluid builds up in the brain. The study aims to gather information about any problems or side effects that patients may experience within two years after receiving this catheter. Researchers will look back at medical records from 200 patients who had the catheter implanted between January 2019 and June 2022. They will review details about the patients' health, the catheter surgery, and any complications that arose, including infections.

To be eligible for this study, participants should have had a Bactiseal catheter implanted for at least two years and must have consented to participate in the research. However, individuals with allergies to the catheter materials, existing infections at the time of surgery, or those who have other medical issues that could complicate the procedure would not be included. If you or a loved one are considering participating, you can expect a thorough review of your medical history and the opportunity to contribute to important research that helps improve treatment safety for future patients.

Gender

ALL

Eligibility criteria

• 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.