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Brain drain device registry completed – no major surprises

NCT ID NCT05652296

Knowledge-focused Sponsor: Integra LifeSciences Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed registry followed 120 patients who received an Integra external ventricular drainage (EVD) system to drain excess fluid from the brain. The goal was to check how well the device performed and how safe it was in real-world use. Researchers measured whether the drainage matched what doctors expected and whether the access kit worked properly.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
External ventricular drainage (EVD) device
What this could lead to
If successful, this registry confirms the device works as intended for draining fluid from the brain, supporting its continued use in hospitals.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove the device is better than alternatives. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

120 people

The number who actually took part.

Started

Mar 2023

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Consecutive patients of any age, and gender who underwent a procedure with one of the Integra External Ventricular Drainage Systems or Accessories

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

central nervous system disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cerebrospinal; disorder

Contacts and locations

Locations

  • AZ Delta

    Roeselare, 8000, Belgium

  • Hôpital Gui de Chauliac

    Montpellier, 34295, France

  • University Hospitals leuven

    Leuven, 3000, Belgium

  • Ziekenhuis Oost-limburg

    Genk, 3600, Belgium

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