CERTAS Programmable Valve Registry

Integra LifeSciences

Status: Completed

Conditions: Hydrocephalus; IIH - Idiopathic Intracranial Hypertension; NPH (Normal Pressure Hydrocephalus)

Treatments: Device: CODMAN CERTAS Programmable Valves

Study type: Observational

Funder types: Industry

Identifiers

NCT04207229

C-CERTAS-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult patients (18-80 years old at time of enrollment) undergoing implantation of the CODMAN CERTAS Plus Programmable Valve according to the device label.
2. Patients willing and able to understand and sign informed consent.

Exclusion criteria

N/A

Trial design

35 participants in 1 patient group

CODMAN CERTAS Programmable Valves

Description:

CODMAN CERTAS Plus Programmable Valve, CODMAN CERTAS Plus Small Inline Programmable Valve, and CODMAN CERTAS Plus Right Angle Programmable Valve.

Treatment:

Device: CODMAN CERTAS Programmable Valves