HydrocephalusCERTASNCT04207229
CERTAS Programmable Valve Registry
An observational study of Hydrocephalus and NPH (Normal Pressure Hydrocephalus), run by Integra LifeSciences Corporation at 8 sites in 2 countries.
Trial summary
Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hydrocephalus, NPH (Normal Pressure Hydrocephalus), IIH - Idiopathic Intracranial Hypertension
- What is being tested?
- CODMAN CERTAS Programmable Valves
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 21 Nov 2019to 18 Nov 2021
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will receive the CODMAN CERTAS Plus Programmable Valve type most applicable for their condition, as determined by their clinician.
Who may be able to join
- 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.
Who cannot join
- N/A
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Germany7 sites
Universitätsklinikum Düsseldorf
Düsseldorf
UniversitätsKlinikum Essen
Essen
Freiburg University Hospital
Freiburg im Breisgau
Universitätsmedizin Mannheim
Mannheim
Klinikum rechts der Isar Technischen Universitat München
München, 81675
München Klinik Bogenhausen
München
Klinikum der LandesHauptStadt Stuttgart gKAôR
Stuttgart
About this study
Official title: Post-Market Clinical Follow-up Registry of Patients With CODMAN CERTAS Plus Programmable Valves
Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.
Read the 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.
- Improvement of the following symptoms related to hydrocephalus:
- Gait disturbances;
- Spatial impairment;
- Cognitive abilities;
- Urinary incontinence;
- Pain caused by headaches;
- Visual acuity.
- Conditions
- Hydrocephalus, NPH (Normal Pressure Hydrocephalus), IIH - Idiopathic Intracranial Hypertension
- Being tested
- CODMAN CERTAS Programmable Valves
- Medical subject headings
- Hydrocephalus, Hydrocephalus, Normal Pressure, Pseudotumor Cerebri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CODMAN CERTAS Programmable ValvesDevice
Patients will undergo implantation of the CODMAN CERTAS Plus Programmable Valve according to the device label.
| Study group | Role | What they receive |
|---|---|---|
| CODMAN CERTAS Programmable Valves | CODMAN CERTAS Plus Programmable Valve, CODMAN CERTAS Plus Small Inline Programmable Valve, and CODMAN CERTAS Plus Right Angle Programmable Valve. Receives: Device: CODMAN CERTAS Programmable Valves |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months
Secondary outcomes (1)
Device Deficiencies
Incidence and nature of device deficiencies
Measured: 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start21 Nov 2019
- Primary completion18 Nov 2021
- Study completion18 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrocephalusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
- Investigators
- Sanja Ilic, MD, Study director, Integra LifeSciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207229
- Sponsor's protocol ID
- C-CERTAS-001
- Acronym
- CERTAS
- Status last verified
- Jan 2022
- First submitted
- 27 Nov 2019
- Last updated
- 26 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Clinical Follow-up Registry of Patients With CODMAN CERTAS Plus Programmable Valves
- ClinicalTrials.gov ID
- NCT04207229
- Acronym / sponsor ID
- CERTAS / C-CERTAS-001
- Conditions
- Hydrocephalus, NPH (Normal Pressure Hydrocephalus), IIH - Idiopathic Intracranial Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Avania
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 18 Nov 2021 (actual)
- Study completion
- 18 Nov 2021 (actual)
- First posted
- 20 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CODMAN CERTAS Programmable Valves | – | Device: CODMAN CERTAS Programmable ValvesCODMAN CERTAS Plus Programmable Valve, CODMAN CERTAS Plus Small Inline Programmable Valve, and CODMAN CERTAS Plus Right Angle Programmable Valve. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will receive the CODMAN CERTAS Plus Programmable Valve type most applicable for their condition, as determined by their clinician.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CODMAN CERTAS Programmable ValvesPatients will undergo implantation of the CODMAN CERTAS Plus Programmable Valve according to the device label. | Device | CODMAN CERTAS Programmable Valves |
Primary outcome
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.
1 secondary outcome
Device Deficiencies
Time frame: 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanja Ilic, MD study director
Integra LifeSciences
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydrocephalus and NPH (Normal Pressure Hydrocephalus), run by Integra LifeSciences Corporation at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance Endpoints (time frame: 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2022.