CERTAS Programmable Valve Registry — CERTAS  

Hydrocephalus Clinical Trial

Official title: Post-Market Clinical Follow-up Registry of Patients With CODMAN CERTAS Plus Programmable Valves

Status Completed

Clinical Trial Summary

Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.

Clinical Trial Description

The CODMAN CERTAS Plus Programmable Valve is a single use implantable device designed for shunting cerebrospinal fluid (CSF) for the treatment of hydrocephalus.

The clinical investigation specifically aims to collect data on the performance measures outlined below. Data will be collected per standard of care, given the nature of the clinical investigation to capture real world data (registry); timing, frequency, and methodology of assessing the performance outcomes may therefore differ per center, subject, and/or visit.

1) Improvement of the following symptoms related to hydrocephalus:

• Gait disturbances;

• Spatial impairment;

• Cognitive abilities;

• Urinary incontinence;

• Pain caused by headaches;

• Visual acuity. ;

Related Conditions & MeSH terms

• Hydrocephalus
• Hydrocephalus, Normal Pressure
• IIH - Idiopathic Intracranial Hypertension
• Intracranial Hypertension
• NPH (Normal Pressure Hydrocephalus)
• Pseudotumor Cerebri

• NCT number: NCT04207229
• Study type: Observational [Patient Registry]
• Source: Integra LifeSciences Corporation
• Status: Completed
• Start date: November 21, 2019
• Completion date: November 18, 2021