Trials / Completed
CompletedNCT04207229
CERTAS Programmable Valve Registry
Post-Market Clinical Follow-up Registry of Patients With CODMAN CERTAS Plus Programmable Valves
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 35 (actual)
- Sponsor
- Integra LifeSciences Corporation · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CODMAN CERTAS Programmable Valves | Patients will undergo implantation of the CODMAN CERTAS Plus Programmable Valve according to the device label. |
Timeline
- Start date
- 2019-11-21
- Primary completion
- 2021-11-18
- Completion
- 2021-11-18
- First posted
- 2019-12-20
- Last updated
- 2022-01-26
Locations
8 sites across 2 countries: Germany, Netherlands
Source: ClinicalTrials.gov record NCT04207229. Inclusion in this directory is not an endorsement.