Phase
Condition
Neurologic Disorders
Treatment
External Ventricular Drainage (EVD)
Clinical Study ID
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient and/or legally authorized representative has agreed to participate in thestudy by signing the EC-approved consent form, where applicable.
Patients (of any age) who underwent or who plan to have a procedure with one of theIntegra or Codman External Ventricular Drainage System.
For patients who have had the EVD System removed prior to study enrollment, haveavailable follow-up data from implant until the EVD System is no longer required fordrainage and monitoring of CSF.
Exclusion
Exclusion Criteria:
The Patients in whom more than one EVD System were or are intended to be placed.
The Patient has sepsis.
The Patient has a history of poor wound healing.
The patient exhibits signs of scalp infection prior to implantation that would becontraindicated per the IFU.
The Patient is otherwise determined by the Investigator to be medically unsuitablefor participation in this Registry.
The Patient is currently enrolled in another device trial or has been previouslyentered in this trial.
The Patient is a prisoner or member of a different vulnerable population that shouldnot be included in the study per the investigator.
The Patients known to have uncorrected coagulopathy.
The Patients with known hypersensitivity to rifampin or clindamycin hydrochloride (prior to implantation of Bactiseal catheters)
Study Design
Study Description
Connect with a study center
Ziekenhuis Oost-limburg
Genk, 3600
BelgiumSite Not Available
University Hospitals leuven
Leuven, 3000
BelgiumSite Not Available
AZ Delta
Roeselare, 8000
BelgiumSite Not Available
Hôpital Gui de Chauliac
Montpellier, 34295
FranceSite Not Available
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