At a glance
ClinicalIndex Comparison RecordN/ACompleted· 50 enrolled
Drug / intervention
Bactiseal Catheterdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-center, Retrospective Registry Study on the Safety of Bactiseal Catheter
In Brief
An observational study evaluating Bactiseal Catheter for Hydrocephalus. Completed, enrolled 50 participants across 3 sites.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsHydrocephalus
CountriesChina
Collaborators--
Timeline
N/ACompletedFinished
202120222023202420252026
First PostedAug 2020
Enrollment StartSep 2020
Primary CompletionNov 2020
TodayJul 2026
First PostedAug 3, 2020
Enrollment StartSep 1, 2020
Primary CompletionNov 30, 2020
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 5.9 years ago
Interventions
Bactiseal Catheterdevice
Bactiseal Catheter manufactured by Codman \& Shurtleff, Inc. in the United States is a silicon catheter impregnated in rifampicin and clindamycin.