Status:
COMPLETED
Bactiseal Catheter Safety Registry in China
Lead Sponsor:
Integra LifeSciences Corporation
Conditions:
Hydrocephalus
Eligibility:
All Genders
Brief Summary
Research Purpose: This study aimed to continue to evaluate safety information from subjects implanted with a catheter (trade name: Bactiseal) produced by Codman \& Shurtleff, Inc. of the United States...
Detailed Description
This study aimed to continue to evaluate safety information from subjects implanted with a catheter (trade name: Bactiseal) produced by Codman \& Shurtleff, Inc. of the United States. Device safety wo...
Eligibility Criteria
Inclusion
- The informed consent was exempted by the Ethics Committee of a research center. Either a subject or his/her legal representative signed the informed consent form (ICF) prior to enrollment.
- A subject had an indication suitable to use Bactiseal Catheter.
- A subject received a hydrocephalus shunt at least one year ago.
Exclusion
- A subject didn't have an indication suitable to use the product.
- A subject was known to be allergic to a component or ingredient of the product to be implanted, including silicone tubing, rifampicin, and clindamycin.
- According to the comprehensive judgment of an investigator, a subject had an infection of the implant site when the shunt was implanted, such as ventriculitis, meningitis, peritonitis, and local implant skin infection.
- A subject was simultaneously implanted with another shunt system 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 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2020
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04496414
Start Date
September 1 2020
End Date
November 30 2020
Last Update
March 28 2023
Active Locations (3)
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1
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100045
2
Beijing Hospital
Beijing, Beijing Municipality, China, 100730
3
Shanghai Children's Medical Center affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200127