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NCT04496414

Bactiseal Catheter Safety Registry in China

A Multi-center, Retrospective Registry Study on the Safety of Bactiseal Catheter
Integra LifeSciences Corporation·ClinicalTrials.gov·device·Device trialCompleted
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Hydrocephalus
Drug/Device/Intervention
Bactiseal Catheter
Study type
Observational
Intervention type
device
Sponsor & location
Primary sponsor
Integra LifeSciences Corporation
Location
Beijing,Beijing,Shanghai, China
Timeline & enrollment
Phase
N/A
Start date
Sep 01, 2020
End date
Nov 30, 2020
Enrollment
50 participants
Primary outcome

50 Participants With Non-infection 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.

ICD-10 classifications
HydrocephalusHydrocephalus, unspecifiedOther hydrocephalusCongenital hydrocephalusObstructive hydrocephalus
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04496414
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT04496414 through Pure Global AI's free database. This phase not specified trial is sponsored by Integra LifeSciences Corporation and is currently Completed. The study focuses on Hydrocephalus. Target enrollment is 50 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.