N/A N=50

Bactiseal Catheter Safety Registry in China

Hydrocephalus

Bottom Line

View on ClinicalTrials.gov: NCT04496414 ↗

Enrolled (actual)

Serious AEs

26.0%

Results posted

Dec 2021

Primary outcome: Primary: 50 Participants With Non-infection Within One Year — 1 Participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Bactiseal Catheter (Device)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Integra LifeSciences Corporation
Primary completion: Nov 2020

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	—	—

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.

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.

View full record on ClinicalTrials.gov →

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.