External Ventricular Drainage Post-Market Clinical Follow-up Registry

• Sponsor: Integra LifeSciences Corporation (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05652296
• Collaborator: (none)
• Enrollment: 120
• Anticipated Duration (Months): 14

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebrospinal; Disorder	Device: External Ventricular Drainage (EVD)

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

• Study Type: Observational
• Anticipated Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Post-Market Clinical Follow-up Registry of the Integra External Ventricular Drainage Systems and Accessories
• Anticipated Study Start Date: Dec 31, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Feb 29, 2024

Outcome Measures

Primary Outcome Measures

1. Procedural Success [48 hours]

   Percentage of subjects with Device success and with no device or procedure related serious adverse events

2. Technical Success [48 hours]

   Percentage of subjects alive with documented placement of an external ventricular drainage system, as required, and with no need for additional unplanned or emergency surgery or re-intervention related to the EVD System or access procedure

3. Device Success [up to 30 days]

   Percentage of subjects alive with original Intended EVD system in place, and with no additional surgical or interventional procedures related to the EVD system since completion of the original procedure (i.e., exit from operating room (OR)), and intended performance of the EVD system

Other Outcome Measures

1. EVD system and accessories related adverse events (AEs) during the use of the EVD system in the patient [up to 30 days]

   Percentage of subjects with EVD system and accessories related adverse events (AEs) during the use of the EVD system in the patient

2. Procedure-related adverse events [up to 30 days]

   Percentage of subjects with procedure-related adverse events

3. Noted Device Deficiencies during use of the EVD system and accessories such as malfunction, use errors, or other issues related to the performance or safety of the External Ventricular Drainage Systems and Accessories [up to 30 days]

   Percentage of subjects with noted Device Deficiencies during use of the EVD system and accessories such as malfunction, use errors, or other issues related to the performance or safety of the External Ventricular Drainage Systems and Accessories

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patient and/or legally authorized representative has agreed to participate in the study by signing the Ethics Committee 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 through removal of the EVD System.

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 has symptoms pertaining to a skin infection at or near the site of any incisions; an ear infection on either side; a respiratory tract infection; or a urinary tract infection that, in the Investigator's opinion is clinically significant and might compromise the outcome of this Registry.

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 drug or 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 receiving anticoagulants.

9. The Patients known to have bleeding diathesis.

10. The Patients with infection within the body, such as meningitis, ventriculitis, peritonitis, bacteremia, and septicemia.

11. The Patients with known hypersensitivity to rifampin or clindamycin hydrochloride. This criterion applies for patients to be treated with the CODMAN® BACTISEAL® Catheters (included in some models of the valve) only.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Integra LifeSciences Corporation

Investigators

• Study Director: Sanja Ilic, MD, Integra LifeSciences Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Integra LifeSciences Corporation
• ClinicalTrials.gov Identifier: NCT05652296
• Other Study ID Numbers: C-EXTVDR-001
• First Posted: Dec 15, 2022
• Last Update Posted: Dec 16, 2022
• Last Verified: Dec 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Central Nervous System Diseases

Study Results

No Results Posted as of Dec 16, 2022