Bactiseal Catheter Safety Registry Study

Recruiting Observational Study
Hydrocephalus
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Sex
Any
Study type
Observational
Participants needed
200 (estimated)
Sponsor
Integra LifeSciences Corporation · Industry
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About This Trial
Research Purpose: This study aims to continuously evaluate the safety of subjects implanted with a catheter (trade name: Bactiseal) produced by Integra LifeSciences Production Corporation. Device safety will be assessed based on all the adverse events that occurred within 2 years after implanted the catheter. Research Design: This study is designed to be single arm, multi-center, and retrospect…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. The informed consent is exempted by the Ethics Committee of a research center. Or a subject or his/her legal representative signed the informed consent form (ICF) prior to the enrollment. 2. A subject had an indication suitable to use Bactiseal Catheter. 3. A subject implante…
Contacts

Hua Tang, MD

0086 21-63179772

hua.tang@integralife.com

CONTACT