Spots Global Cancer Trial Database for Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve

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Trial Identification

Brief Title: Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve

Official Title: Post-Market Clinical Follow-up of Patients With CODMAN CERTAS Plus Programmable Valve

Study ID: NCT05397106

Conditions

Hydrocephalus

Hydrocephalus in Children

NPH (Normal Pressure Hydrocephalus)

IIH - Idiopathic Intracranial Hypertension

Brain Tumor

Post-Traumatic Hydrocephalus

Hemorrhagic Stroke

Interventions

CODMAN CERTAS Plus Programmable Valve

Study Description

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 valve can be set to 8 different performance settings for intraventricular pressure and drainage of CSF. The performance setting of the valve can be set preoperatively and can also be noninvasively changed post-implantation. This clinical investigation will maintain data for each patient from the date of implant through 3 years post-implantation. Data collection for each patient will occur per standard of care. However, the clinical investigation specifically aims to collect and analyze data from the day of procedure, and post-operatively at 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months. Data from follow-up visits will be analyzed according to pre-defined time-intervals referring to these follow-up moments.