Bactiseal Catheter Safety Registry in China

Status Completed

Clinical Trial 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.

Clinical Trial 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 would be assessed based on all the adverse events that occurred within one year after the subjects implanted the catheter. This study was designed to be single arm, multi-center, and retrospective. A total of 50 patients would be retrospectively enrolled. Information would be collected on adverse events of subjects enrolled within one year after the implantation of the Bactiseal Catheter from August 07, 2018 to Novemver 30, 2020. The following information would be collected from subjects' medical records or hospitals' databases (if any): 1. General condition of the subjects 2. Intraoperative condition and catheter implantation 3. Information on the shunt product 4. Adverse events of subjects within one year after the operation and classification of the adverse events 5. Relevant examinations in case of postoperative infection 6. Other adverse event-related information (except anticipated adverse events) ;

Study Design

Related Conditions & MeSH terms

Hydrocephalus

Clinical Trial Details

NCT number	NCT04496414
Study type	Observational [Patient Registry]
Source	Integra LifeSciences Corporation
Contact
Status	Completed
Phase
Start date	September 1, 2020
Completion date	November 30, 2020

View Details

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