CERTAS Programmable Valve Registry

Hydrocephalus Clinical Trial

— CERTAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04207229
• Other study ID #: C-CERTAS-001
• Status: Completed
• Start date: November 21, 2019
• Est. completion date: November 18, 2021

Study information

• Verified date: January 2022
• Source: Integra LifeSciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 18, 2021
• Est. primary completion date: November 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Germany	Universitätsklinikum Düsseldorf	Düsseldorf
Germany	UniversitätsKlinikum Essen	Essen
Germany	Freiburg University Hospital	Freiburg
Germany	Universitätsmedizin Mannheim	Mannheim
Germany	Klinikum rechts der Isar Technischen Universitat München	München
Germany	München Klinik Bogenhausen	München
Germany	Klinikum der LandesHauptStadt Stuttgart gKAôR	Stuttgart
Netherlands	Erasmus University Medical Center	Rotterdam

Sponsors (2)

Lead Sponsor	Collaborator
Integra LifeSciences Corporation	Avania

Countries where clinical trial is conducted

Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Endpoints: Incidence and nature of adverse device effects	Incidence and nature of adverse device effects	1 month, 3 months, 6 months, 12 months, 24 months, and 36 months
Primary	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.	1 month, 3 months, 6 months, 12 months, 24 months, and 36 months
Secondary	Device Deficiencies	Incidence and nature of device deficiencies	1 month, 3 months, 6 months, 12 months, 24 months, and 36 months