External Ventricular Drainage Post-Market Clinical Follow-up Registry

Cerebrospinal; Disorder Clinical Trial

Official title:

Post-Market Clinical Follow-up Registry of the Integra External Ventricular Drainage Systems and Accessories

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05652296
• Other study ID #: C-EXTVDR-001
• Status: Recruiting
• Start date: March 3, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: September 2023
• Source: Integra LifeSciences Corporation
• Contact: Habib Nacer-Cherif
• Phone: +33 (0)6 26 19 00 29
• Email: habib.nacercherif[@]integralife.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Central Nervous System Diseases
• Cerebrospinal; Disorder

Intervention

Device:
• External Ventricular Drainage (EVD)
EVD of Cerebral Spinal Fluid from the lateral ventricles of the brain

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-limburg	Genk
Belgium	University Hospitals leuven	Leuven
Belgium	AZ Delta	Roeselare
France	Hôpital Gui de Chauliac	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Integra LifeSciences Corporation

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Device- or procedure related adverse events (AEs) during the use of the device in the patient	Percentage of subjects with device related adverse events (AEs) during the use of the device in the patient	Through study completion, an average of 2 years
Other	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	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	Through study completion, an average of 2 years
Primary	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.	Through study completion, an average of 2 years
Secondary	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.	Through study completion, an average of 2 years