An observational study in Hydrocephalus, sponsored by Integra LifeSciences Corporation. Recruiting at 8 sites in China. Per ClinicalTrials.gov, last updated 2025-01-27.
Sponsored by Integra LifeSciences Corporation · Observational
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 retrospective. A total of 200 subjects will be retrospectively enrolled. Information will be collected on adverse events, including bacterial culture and drug resistance testing when infection (if done), of subjects enrolled within 2 years after the implantation of the Bactiseal Catheter between January 01, 2019 and June 30, 2022.
The following information will be collected from subjects' medical records or hospitals' databases (if any):
190 studies on the registry are indexed under Hydrocephalus; 52 are open to participants now.
This study's planned enrollment of 200 is above the median of 73 across 86 observational studies indexed under Hydrocephalus.
Browse Hydrocephalus studies →Integra LifeSciences Corporation is the lead sponsor of 82 studies on the registry; 5 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
A total of 200 hydrocephalus patients will be enrolled and adverse events will be collected for those enrolled subjects within two years after the implantation of the Bactiseal catheter from January 01, 2019 to June 30, 2022, through reviewing subject record or hospital database.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hydrocephalus patients implanted with antibiotic-impregnated catheter.
Device: antibiotic-impregnated catheter
Hydrocephalus patient implant with antibiotic-impregnated catheter to shunt their cerebrospinal fluid.
Infection outcome
Incidence of Bactiseal Shunt catheter related infection within 2 years post implant.
Time frame: 2 years post catheter implanted.
Safety outcome
Incidence of adverse events of a subject within 2 years post implant Bactiseal
Time frame: 2 years post catheter implanted.
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Plan to share: No — individual participant data (IPD) is not available to other researchers.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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