External Ventricular Drainage (EVD)
DeviceEVD of Cerebral Spinal Fluid from the lateral ventricles of the brain
NCT Number: NCT05652296
This post-market follow-up registry will capture clinical data specific to the safety and performance of the Integra External Ventricular Drainage Systems and Accessories.
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Observational
Ziekenhuis Oost-limburg, Genk, Belgium
The purpose of this study is to investigate whether the Integra External Ventricular Drainage System listed as part of this study do perform to clinical expectations.
Additionally, this study will focus on the safety of these devices by collecting any device-specific Adverse Events (AEs) or Device deficiencies (DDs) seen when used during standard of care procedures.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
EVD of Cerebral Spinal Fluid from the lateral ventricles of the brain
Time frame: 1 month following device implantation
Percentage of subjects with anticipated drainage (i.e., observed drainage consistent with the patient's clinical presentation) of cerebrospinal fluid (CSF) in the clinical setting until the EVD System is no longer required.
Time frame: 1 month following device implantation
Percentage of subjects in whom the CODMAN Cranial Access Kit, when used with appropriate accessories, provided successful access to the intracranial space.
Time frame: 1 month following device implantation
Percentage of subjects with device related adverse events (AEs) during the use of the device in the patient
Time frame: 1 month following device implantation
Percentage of subjects with noted Device Deficiencies during use of the device such as malfunction, use errors, or other issues related to the performance or safety of the External Ventricular Drainage Systems and Accessories
Integra LifeSciences Corporation
Industry
Post-Market Clinical Follow-up Registry of the Integra External Ventricular Drainage Systems and Accessories
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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