Clinical trial NCT05652296: External Ventricular Drainage Post-Market Clinical Follow-up Registry
Official title: Post-Market Clinical Follow-up Registry of the Integra External Ventricular Drainage Systems and Accessories
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebrospinal; Disorder
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2022-12-15
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients of any age, and gender who underwent a procedure with one of the Integra External Ventricular Drainage Systems or Accessories

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Anticipated drainage of cerebrospinal fluid (CSF)
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Success of the access to the intracranial space
timeFrame: Through study completion, an average of 2 years
Other outcomes:
measure: Device- or procedure related adverse events (AEs) during the use of the device in the patient
timeFrame: Through study completion, an average of 2 years
measure: 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
timeFrame: Through study completion, an average of 2 years
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-limburg
city: Leuven
country: Belgium
facility: University Hospitals leuven
city: Roeselare
country: Belgium
facility: AZ Delta
city: Montpellier
country: France
facility: Hôpital Gui de Chauliac
Study officials:
affiliation: Integra LifeSciences Corporation
name: Jason Marzuola
role: STUDY_DIRECTOR
References: