N/A
Completed N=50
Bactiseal Catheter Safety Registry in China
Source: ClinicalTrials.gov NCT04496414 ↗Enrolled (actual)
50
Serious AEs
26.0%
Results posted
Dec 2021
Primary outcomePrimary: 50 Participants With Non-infection Within One Year — 1 Participants
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. Device safety would be assessed based on all the adverse events that occurred within one year after the subjects implanted the catheter.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 50 Participants With Non-infection Within One Year |
1 | — |
| SECONDARY Type and Incidence of Adverse Events of 50 Subjects Within One Year |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04496414). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.