CERTAS Programmable Valve Registry

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04207229

Acronym

CERTAS

Enrollment

Registered

2019-12-20

Start date

2019-11-21

Completion date

2021-11-18

Last updated

2022-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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

Detailed 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.

Interventions

DEVICECODMAN CERTAS Programmable Valves

Patients will undergo implantation of the CODMAN CERTAS Plus Programmable Valve according to the device label.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Performance Endpoints	1 month, 3 months, 6 months, 12 months, 24 months, and 36 months	The change from baseline for the following symptoms related to hydrocephalus, e.g. gait disturbances, spatial impairment, cognitive abilities, urinary incontinence, pain caused by headaches and visual acuity.

Secondary

Measure	Time frame	Description
Device Deficiencies	1 month, 3 months, 6 months, 12 months, 24 months, and 36 months	Incidence and nature of device deficiencies

Other

Measure	Time frame	Description
Safety Endpoints: Incidence and nature of adverse device effects	1 month, 3 months, 6 months, 12 months, 24 months, and 36 months	Incidence and nature of adverse device effects

Countries

Germany, Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026