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Not Yet Recruiting NCT05652296

External Ventricular Drainage Post-Market Clinical Follow-up Registry

Conditions: Cerebrospinal; Disorder

Sex: All
Enrollment: 120
Sponsor: Integra LifeSciences Corporation

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.

Eligibility Criteria

Inclusion Criteria:Patient and/or legally authorized representative has agreed to participate in the study by signing the Ethics Committee 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 through removal of the EVD System.Exclusion Criteria: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 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.The Patient is otherwise determined by the Investigator to be medically unsuitable for participation in this Registry.The Patient is currently enrolled in another drug or device trial or has been previously entered in this trial.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 receiving anticoagulants.The Patients known to have bleeding diathesis.The Patients with infection within the body, such as meningitis, ventriculitis, peritonitis, bacteremia, and septicemia.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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05652296). StuddyBuddy aggregates publicly available trial information.