Cerebrospinal; Disorder
Conditions
Brief summary
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.
Detailed description
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.
Interventions
EVD of Cerebral Spinal Fluid from the lateral ventricles of the brain
Sponsors
Integra LifeSciences Corporation
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Patient and/or legally authorized representative has agreed to participate in the study by signing the EC-approved consent form, where applicable. 2. Patients (of any age) who underwent or who plan to have a procedure with one of the Integra or Codman External Ventricular Drainage System. 3. For patients who have had the EVD System removed prior to study enrollment, have available follow-up data from implant until the EVD System is no longer required for drainage and monitoring of CSF.
Exclusion criteria
1. The Patients in whom more than one EVD System were or are intended to be placed. 2. The Patient has sepsis. 3. The Patient has a history of poor wound healing. 4. The patient exhibits signs of scalp infection prior to implantation that would be contraindicated per the IFU. 5. The Patient is otherwise determined by the Investigator to be medically unsuitable for participation in this Registry. 6. The Patient is currently enrolled in another device trial or has been previously entered in this trial. 7. The Patient is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator. 8. The Patients known to have uncorrected coagulopathy. 9. The Patients with known hypersensitivity to rifampin or clindamycin hydrochloride (prior to implantation of Bactiseal catheters)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anticipated Drainage of Cerebrospinal Fluid (CSF) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success of the Access to the Intracranial Space | 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. |
Countries
Belgium, France
Contacts
STUDY_DIRECTORJason Marzuola
Integra LifeSciences Corporation
Participant flow
Recruitment details
Consecutive subjects of any age, and gender who gave consent for study participation, and who met the eligibility criteria and, who underwent a procedure with one of the Integra External Ventricular Drainage Systems or Accessories were enrolled into the study. The enrollment occured at at four sites in EU: three in Belgium and one in France.
Pre-assignment details
A total of 120 patients, ie, the full consecutive series of patients from study sites were screened, and 117 subjects were included in this study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 54.8 years STANDARD_DEVIATION 18.49 |
| Region of Enrollment Belgium | 79 participants |
| Region of Enrollment France | 38 participants |
| Sex: Female, Male Female | 59 Participants |
| Sex: Female, Male Male | 58 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 10 / 117 |
| other Total, other adverse events | 54 / 117 |
| serious Total, serious adverse events | 59 / 117 |
Outcome results
None listed