NCT05397106

Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 160 (actual)
• Sponsor: Integra LifeSciences Corporation · Industry
• Sex: All
• Age: —
• 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 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.

Conditions

• Hydrocephalus
• Hydrocephalus in Children
• NPH (Normal Pressure Hydrocephalus)
• IIH - Idiopathic Intracranial Hypertension
• Brain Tumor
• Post-Traumatic Hydrocephalus
• Hemorrhagic Stroke

Interventions

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

Timeline

• Start date: 2023-01-24
• Primary completion: 2029-01-24
• Completion: 2029-01-24
• First posted: 2022-05-31
• Last updated: 2026-02-27

Locations

9 sites across 4 countries: Belgium, Germany, Spain, Switzerland