Status:
RECRUITING
Bactiseal Catheter Safety Registry Study
Lead Sponsor:
Integra LifeSciences Corporation
Conditions:
Hydrocephalus
Eligibility:
All Genders
Brief 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 saf...
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Key Trial Info
Start Date :
September 29 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06276543
Start Date
September 29 2024
End Date
December 31 2026
Last Update
January 27 2025
Active Locations (8)
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1
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100053
2
Beijing Hospital
Beijing, Beijing Municipality, China, 100730
3
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510280
4
the 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China