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Completed

NCT Number: NCT04207229

CERTAS Programmable Valve Registry

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

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Key information

Conditions

Hydrocephalus Brain Diseases Central Nervous System Diseases Hydrocephalus, Normal Pressure IIH - Idiopathic Intracranial Hypertension Intracranial Hypertension NPH (Normal Pressure Hydrocephalus) Nervous System Diseases Pseudotumor Cerebri

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Düsseldorf, Düsseldorf, Germany

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About this study

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.

  • Improvement of the following symptoms related to hydrocephalus:
  • Gait disturbances;
  • Spatial impairment;
  • Cognitive abilities;
  • Urinary incontinence;
  • Pain caused by headaches;
  • Visual acuity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (18-80 years old at time of enrollment) undergoing implantation of the CODMAN CERTAS Plus Programmable Valve according to the device label.
  • Patients willing and able to understand and sign informed consent.

Exclusion criteria

N/A

Treatment and study plan

CODMAN CERTAS Programmable Valves

Device

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

Primary outcomes

  1. Performance Endpoints

    Time frame: 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months

    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.

Secondary outcomes

  1. Device Deficiencies

    Time frame: 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months

    Incidence and nature of device deficiencies

Other outcomes

  1. Safety Endpoints: Incidence and nature of adverse device effects

    Time frame: 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months

    Incidence and nature of adverse device effects

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Collaborators

  • Avania

Registry information

Official study title

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

Acronym: CERTAS

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 20, 2019
Registry last updated
Jan 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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