CERTAS Programmable Valve Registry

• Sponsor: Integra LifeSciences Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04207229
• Collaborator: Avania (Industry)
• Enrollment: 35
• Locations: 8
• Actual Duration (Months): 23.9
• Patients Per Site: 4.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hydrocephalus; NPH (Normal Pressure Hydrocephalus); IIH - Idiopathic Intracranial Hypertension	Device: CODMAN CERTAS 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 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.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 35 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Post-Market Clinical Follow-up Registry of Patients With CODMAN CERTAS Plus Programmable Valves
• Actual Study Start Date: Nov 21, 2019
• Actual Primary Completion Date: Nov 18, 2021
• Actual Study Completion Date: Nov 18, 2021

Arms and Interventions

Arm	Intervention/Treatment
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; Patients will undergo implantation of the CODMAN CERTAS Plus Programmable Valve according to the device label.

Outcome Measures

Primary Outcome Measures

1. Performance Endpoints [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 Outcome Measures

1. Device Deficiencies [1 month, 3 months, 6 months, 12 months, 24 months, and 36 months]

   Incidence and nature of device deficiencies

Other Outcome Measures

1. Safety Endpoints: Incidence and nature of adverse device effects [1 month, 3 months, 6 months, 12 months, 24 months, and 36 months]

   Incidence and nature of adverse device effects

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitätsklinikum Düsseldorf	Düsseldorf		Germany
2	UniversitätsKlinikum Essen	Essen		Germany
3	Freiburg University Hospital	Freiburg		Germany
4	Universitätsmedizin Mannheim	Mannheim		Germany
5	Klinikum rechts der Isar Technischen Universitat München	München		Germany	81675
6	München Klinik Bogenhausen	München		Germany
7	Klinikum der LandesHauptStadt Stuttgart gKAôR	Stuttgart		Germany
8	Erasmus University Medical Center	Rotterdam		Netherlands

Sponsors and Collaborators

• Integra LifeSciences Corporation
• Avania

Investigators

• Study Director: Sanja Ilic, MD, Integra LifeSciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Integra LifeSciences Corporation
• ClinicalTrials.gov Identifier: NCT04207229
• Other Study ID Numbers: C-CERTAS-001
• First Posted: Dec 20, 2019
• Last Update Posted: Jan 26, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Hydrocephalus; Intracranial Hypertension; Hydrocephalus, Normal Pressure; Pseudotumor Cerebri

Study Results

No Results Posted as of Jan 26, 2022