Bactiseal Catheter Safety Registry in China

Learn more about:
Related Clinical Trial
EVD Drainage Data and Intracranial Pressure (ICP) Measurements Caregiver Burden and Anxiety in Mothers of Children With Hydrocephalus Comparison of Programmable and Non-programmable CSF Shunts Among Adult Hydrocephalus Patients With Different Etiologies Pilot Study to Evaluate the CereVasc® eShunt® System in the Treatment of Communicating Hydrocephalus Improvement of Peritoneal Catheter Placement in VPS With a Splitable Trocar Assessment of CSF Shunt Flow With Thermal Measurements B The Role of Neurofilament Light (NfL) in Patients With Hydrocephalus: A Pilot Study Quantitative Pupillometry Pilot Study to Evaluate the CereVasc® eShunt® System US Pilot Study to Evaluate the CereVasc® eShunt® System Prediction Model of Improvement of Disturbance of Consciousness in Patients With Hydrocephalus After Shunt Operation Combined Flow and Pressure Study of Craniospinal Dynamic Assessment of CSF Shunt Flow With Thermal Measurements Prophylactic Antibiotics Useful With Antibiotic Impregnated External Ventricular Drains (EVDs)? Brain Aneurysms: Utility of Cisternal Urokinase Irrigation Three-step Disinfection Reduce the Postoperative Infection Rate of Ventriculoperitoneal Shunt Endoscopic Third Ventriculostomy for Adults: A Prognostic Model for Success The ETCHES I Study (Endovascular Treatment of Communicating Hydrocephalus With an Endovascular Shunt) Pupillometry : Predictive Indicator in External Ventricular Drain Clamping ? Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients’ Treatment Early Ventriculo-peritoneal Shunt in Subarachnoid Patients With External Ventricular Drainage Bactiseal Catheter Safety Registry in China Intraoperative Ultrasound Guided Compared to Stereotactic Navigated Ventriculoperitoneal Shunt Placement Hyperfine Portable MRI in Hydrocephalus Expanded Access Protocol: Umbilical Cord Blood Infusions for Children With Brain Injuries An Evaluation of a Non-invasive Brain Monitor An Evaluation of Non-Invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an Intraparenchymal Pressure Monitoring Device Assess Specific Kinds of Children Challenges for Neurologic Devices Study A Secondary Study Evaluating Aqueduct’s Smart External Drain (SED) Simulation Efficacy in Neurosurgical Education Intraoral 30% Glucose Effect In Newborns The Prediction of Intracranial Pressure and Clinical Outcome by Transcranial Doppler in Neurocritical Patients Impact of Ventricular Catheter Used With Antimicrobial Agents on Patients With a Ventricular Catheter Subgaleal Drains in Decompressive Craniectomies Role of Proteomics and Metallomics in Cerebral Vasospasm Following Subarachnoid Hemorrhage A Study Evaluate Aqueduct’s Smart External Drain Quality of Life in Elderly After Aneurysmal Subarachnoid Hemorrhage (SAH) Optimizing Treatment of Post-hemorrhagic Ventricular Dilation in Preterm Infants Intraventricular Drain Insertion: Comparison of Ultrasound-guided and Landmark-based Puncture of the Ventricular System Quantitative Characterization of Safe Irrigation for Ventricular Shunt Catheters Study of Ultrasound of the Eye for Children With Suspected Shunt Failure MR Evaluation of Cerebrospinal Fluid (CSF) Dynamics Tablet-guided Versus Freehand (Tab-Guide) Ventriculostomy : Study Protocol to the Test Accuracy of Ventriculostomy in a Randomized Controlled Trial Sonographic Monitoring of Weaning of Cerebrospinal Fluid Drainages Effect of Intraventricular tPA Following Aneurysmal Subarachnoid Hemorrhage A Precision and Accuracy Study of the Codman Valve Position Verification (VPV) System. Danish RAndomized Trial of External Ventricular Drainage Cessation IN Aneurysmal Subarachnoid Haemorrhage Brain Ultrasound in the Weaning of External Ventricular Leads A Study on the Safety of Hakim Programmable Shunt System Thermal Camera Detection of Ventriculoperitoneal Shunt Flow Non-invasive Epicutaneous Transfontanel Intracranial Pressure Monitoring in Children Under the Age of One: a Novel Technique Bench Study of Transcutaneous Hydrocephalic Shunt Flow Sensor Alignment Accuracy and Repeatability NIMIP: Non Invasive Measurement of the Intracranial Pressure Linking Digital Smartphone Behaviour With Brain Function Study of Shunt Flow Sensor Accuracy in Extra-ventricular Drains. Blood and Cerebrospinal Fluid for Pediatric Brain Tumor Research Comparison of Continuous Noninvasive and Invasive Intracranial Pressure Measurement–Celda Infusion Subprotocol Strata Programmable CSF Shunt Valve Study The CSF Shunt Entry Site Trial Guided Application of Ventricular Catheters Value of MRI CSF Flowmetry in Assessment of Grey Zone Hydrocephalic Patients Diagnosing Malfunctioning Hydrocephalic Shunt Valves With a Flow Sensor Comparison of Optic Nerve Sheath Diameter Measured by Ultrasonography Before and After Ventriculoperitoneal Shunt Surgery in Adult Patients With Hydrocephalus CRT ShuntCheck “Fit & Function” Study Monitoring Patient Cerebro-Spinal Fluid Drainage With an Ultrasonic Flow Sensor Cerebrospinal Fluid Proteom in Dependence of Intranasal Breast Milk NIRS Monitoring in Premature Infants Comparison of Optic Nerve Sheath Diameter on Retrobulbar Ultrasound Before and After Drainage of Cerebrospinal Fluid in Patient With Hydrocephalus Comparison of Optic Nerve Sheath Diameter on Retrobulbar Ultrasonography Before and After Drainage of Cerebrospinal Fluid in Pediatric Patient With Hydrocephalus ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients Isoflurane-induced Neuroinflammation in Children With Hydrocephalus Hydrocephalus iPad-App Based Intervention Study Multimodal Investigation in the Diagnosis and Treatment of Chronic Adult Hydrocephalus A Study Comparing Two Treatments for Infants With Hydrocephalus A Registry for Comparing Catheter-Related Infection Rates Among Various Shunt Systems in the Treatment of Hydrocephalus Efficacy Study of Hydrocephalus Surgery by Methods of Neuroelectrophysiology Study of Choroid Plexus Cauderization in Patients With Hydrocephalus ETV Versus Shunt Surgery in Normal Pressure Hydrocephalus BIS Monitoring of Patients With Hydrocephalus Magnetic Resonance Elastography in Hydrocephalus Noninvasive Intracranial Pressure and Hydrocephalus Patients Ventricular Size Involvement in Neuropsychological Outcomes in Pediatric Hydrocephalus HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants

Brief Title

Bactiseal Catheter Safety Registry in China

Official Title

A Multi-center, Retrospective Registry Study on the Safety of Bactiseal Catheter

Brief 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.

Detailed 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 Type

Observational [Patient Registry]

Primary Outcome

50 Participants With Non-infection Within One Year

Secondary Outcome

 Type and Incidence of Adverse Events of 50 Subjects Within One Year




Bactiseal Catheter


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

September 1, 2020

Completion Date

November 30, 2020

Primary Completion Date

November 30, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  The informed consent was exempted by the Ethics Committee of a research center. Either
             a subject or his/her legal representative signed the informed consent form (ICF) prior
             to enrollment.

          -  A subject had an indication suitable to use Bactiseal Catheter.

          -  A subject received a hydrocephalus shunt at least one year ago.

        Exclusion Criteria:

          -  A subject didn't have an indication suitable to use the product.

          -  A subject was known to be allergic to a component or ingredient of the product to be
             implanted, including silicone tubing, rifampicin, and clindamycin.

          -  According to the comprehensive judgment of an investigator, a subject had an infection
             of the implant site when the shunt was implanted, such as ventriculitis, meningitis,
             peritonitis, and local implant skin infection.

          -  A subject was simultaneously implanted with another shunt system different from
             Bactiseal Catheter.

          -  A subject had a contraindication of the shunt operation.

          -  A subject had uncorrected coagulopathy or any bleeding disorder.




N/A - N/A

Accepts Healthy Volunteers



Hua Tang, MD, , 

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party


Study Sponsor

Integra LifeSciences Corporation

Study Sponsor

Hua Tang, MD, Study Director, Integra Life Sciences

Verification Date

August 2022