CERTAS Programmable Valve Registry

NCT04207229 | Completed

• 1 other identifier: C-CERTAS-001
• Study Type: observational
• Target: 35
• Locations: 2 countries
• Sites: 8

Brief Summary

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

Conditions

Hydrocephalus; NPH (Normal Pressure Hydrocephalus); IIH - Idiopathic Intracranial Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Device Deficiencies

  1 month, 3 months, 6 months, 12 months, 24 months, and 36 months

Other Outcomes (1)

• Safety Endpoints: Incidence and nature of adverse device effects

  1 month, 3 months, 6 months, 12 months, 24 months, and 36 months

Study Arms (1)

CODMAN CERTAS Programmable Valves

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

Interventions

CODMAN CERTAS Programmable Valves DEVICE

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

CODMAN CERTAS Programmable Valves

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients will receive the CODMAN CERTAS Plus Programmable Valve type most applicable for their condition, as determined by their clinician.

You may qualify if:

• 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.

You may not qualify if:

• N/A

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead
• Avania: collaborator

Study Sites (8)

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Location

UniversitätsKlinikum Essen

Essen, Germany

Location

Freiburg University Hospital

Freiburg im Breisgau, Germany

Location

Universitätsmedizin Mannheim

Mannheim, Germany

Location

Klinikum rechts der Isar Technischen Universitat München

München, 81675, Germany

Location

München Klinik Bogenhausen

München, Germany

Location

Klinikum der LandesHauptStadt Stuttgart gKAôR

Stuttgart, Germany

Location

Erasmus University Medical Center

Rotterdam, Netherlands

Location

MeSH Terms

Conditions

Hydrocephalus; Hydrocephalus, Normal Pressure; Pseudotumor Cerebri

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hypertension

Study Officials

• Sanja Ilic, MD

  Integra LifeSciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: December 20, 2019
• Study Start: November 21, 2019
• Primary Completion: November 18, 2021
• Study Completion: November 18, 2021
• Last Updated: January 26, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (7); NL (1)