Cerebrospinal; DisorderNCT05652296
External Ventricular Drainage Post-Market Clinical Follow-up Registry
An observational study of Cerebrospinal; Disorder, run by Integra LifeSciences Corporation at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebrospinal; Disorder
- What is being tested?
- External Ventricular Drainage (EVD)
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 3 Mar 2023to 16 Dec 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive patients of any age, and gender who underwent a procedure with one of the Integra External Ventricular Drainage Systems or Accessories
Who may be able to join
- Patient and/or legally authorized representative has agreed to participate in the study 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 the Integra or Codman External Ventricular Drainage System.
- 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.
Who cannot join
- 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 be contraindicated per the IFU.
- The Patient is otherwise determined by the Investigator to be medically unsuitable for participation in this Registry.
- The Patient is currently enrolled in another device trial or has been previously entered in this trial.
Show all 9Show fewer
- The Patient is a prisoner or member of a different vulnerable population that should not 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)
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Belgium3 sites
Ziekenhuis Oost-limburg
Genk, 3600
University Hospitals leuven
Leuven, 3000
AZ Delta
Roeselare, 8000
About this study
Official title: Post-Market Clinical Follow-up Registry of the Integra External Ventricular Drainage Systems and Accessories
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.
Read the 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.
- Conditions
- Cerebrospinal; Disorder
- Being tested
- External Ventricular Drainage (EVD)
- Medical subject headings
- Central Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Ventricular Drainage (EVD)Device
EVD of Cerebral Spinal Fluid from the lateral ventricles of the brain
What is being measured
The primary outcome is the main question the study is designed to answer.
Anticipated Drainage of Cerebrospinal Fluid (CSF)
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.
Measured: 1 month following device implantation
Secondary outcomes (1)
Success of the Access to the Intracranial Space
Percentage of subjects in whom the CODMAN Cranial Access Kit, when used with appropriate accessories, provided successful access to the intracranial space.
Measured: 1 month following device implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start3 Mar 2023
- Primary completion16 Dec 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cerebrospinal; DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Marzuola, Study director, Integra LifeSciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652296
- Sponsor's protocol ID
- C-EXTVDR-001
- Status last verified
- Jan 2026
- First submitted
- 7 Dec 2022
- Last updated
- 28 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Follow-up Registry of the Integra External Ventricular Drainage Systems and Accessories
- ClinicalTrials.gov ID
- NCT05652296
- Acronym / sponsor ID
- C-EXTVDR-001
- Conditions
- Cerebrospinal; Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 15 Dec 2022 (actual)
- Results
- Posted 28 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive patients of any age, and gender who underwent a procedure with one of the Integra External Ventricular Drainage Systems or Accessories
Key inclusion criteria (3 listed)
- Patient and/or legally authorized representative has agreed to participate in the study 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 the Integra or Codman External Ventricular Drainage System.
- 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.
Key exclusion criteria (9 listed)
- 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 be contraindicated per the IFU.
- The Patient is otherwise determined by the Investigator to be medically unsuitable for participation in this Registry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External Ventricular Drainage (EVD)EVD of Cerebral Spinal Fluid from the lateral ventricles of the brain | Device | – |
Primary outcome
Anticipated Drainage of Cerebrospinal Fluid (CSF)
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.
1 secondary outcome
Success of the Access to the Intracranial Space
Time frame: 1 month following device implantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Marzuola study director
Integra LifeSciences Corporation
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrospinal; Disorder, run by Integra LifeSciences Corporation at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anticipated Drainage of Cerebrospinal Fluid (CSF) (time frame: 1 month following device implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.