An observational study in Hydrocephalus, NPH (Normal Pressure Hydrocephalus) and IIH - Idiopathic Intracranial Hypertension, sponsored by Integra LifeSciences Corporation. Completed at 8 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-01-26.
Sponsored by Integra LifeSciences Corporation · Observational
Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.
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.
210 studies on the registry are indexed under Hydrocephalus; 51 are open to participants now.
This study's enrollment of 35 is below the median of 60 across 98 observational studies indexed under Hydrocephalus.
Browse Hydrocephalus studies →Integra LifeSciences Corporation is the lead sponsor of 81 studies on the registry; 5 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients will receive the CODMAN CERTAS Plus Programmable Valve type most applicable for their condition, as determined by their clinician.
Exclusion Criteria:
N/A
CODMAN CERTAS Plus Programmable Valve, CODMAN CERTAS Plus Small Inline Programmable Valve, and CODMAN CERTAS Plus Right Angle Programmable Valve.
Device: CODMAN CERTAS Programmable Valves
Patients will undergo implantation of the CODMAN CERTAS Plus Programmable Valve according to the device label.
Performance Endpoints
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.
Time frame: 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months
Device Deficiencies
Incidence and nature of device deficiencies
Time frame: 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months
Safety Endpoints: Incidence and nature of adverse device effects
Incidence and nature of adverse device effects
Time frame: 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Integra LifeSciences Corporation