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Bactiseal Catheter Safety Registry in China - Trial NCT04496414

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.

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NCT04496414
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Trial Details
ClinicalTrials.gov โ€ข NCT04496414
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Bactiseal Catheter Safety Registry in China
A Multi-center, Retrospective Registry Study on the Safety of Bactiseal Catheter

Study Focus

Hydrocephalus

Bactiseal Catheter

Observational

device

Sponsor & Location

Integra LifeSciences Corporation

Beijing,Beijing,Shanghai, China

Timeline & Enrollment

N/A

Sep 01, 2020

Nov 30, 2020

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

Hydrocephalus
Hydrocephalus, unspecified
Other hydrocephalus
Congenital hydrocephalus
Obstructive hydrocephalus

Data Source

ClinicalTrials.gov

NCT04496414

Device Trial