Cerebrospinal Fluid LeakNCT04057157
Post-market Assessment of Biodesign Dural Repair Grafts
An observational study of Cerebrospinal Fluid Leak, run by Cook Research Incorporated at 3 sites in 3 countries.
Trial summary
The purpose of this clinical study is to gather post-market clinical evidence on the use of the Biodesign® Dural and Duraplasty Grafts when used as a dura substitute of the dura mater. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrospinal Fluid Leak
- What is being tested?
- Biodesign Dural or Duraplasty Repair Grafts
- Type of treatment
- Medical device
- How many people
- 128 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 3 Sep 2019to 15 Sep 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have had dura mater repair using a Biodesign Dural or Duraplasty Graft.
Who may be able to join
- 1. Planned use of the Biodesign Dural or Duraplasty Graft.
Who cannot join
- Age <18 years
- Unable or unwilling to provide informed consent
- Life expectancy <6 months
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United States1 site
University of Alabama Birmingham Hospital
Birmingham, Alabama, 35294
About this study
Official title: Post-market Clinical Data Collection Plan for the Biodesign® Dural and Duraplasty Grafts
The purpose of this clinical study is to gather post-market clinical evidence on the use of the Biodesign® Dural and Duraplasty Grafts when used as a dura substitute of the dura mater.
- Conditions
- Cerebrospinal Fluid Leak
- Being tested
- Biodesign Dural or Duraplasty Repair Grafts
- Keywords
- dura mater repair, cerebrospinal fluid leak, CSF leak, Biodesign® Dural Repair Graft, Biodesign® Duraplasty Repair Graft
- Medical subject headings
- Cerebrospinal Fluid Leak, Cerebrospinal Fluid Otorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biodesign Dural or Duraplasty Repair GraftsDevice
Patients will receive the Biodesign Dural or Duraplasty Repair Grafts according to the Instruction for Use.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients without clinically relevant cerebrospinal fluid (CSF) leakage
Clinically relevant CSF leakage is when it requires treatment (e.g., lumbar drain or surgical repair) or leads to an infection of the central nervous system (e.g., meningitis).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start3 Sep 2019
- Primary completion6 Jun 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrospinal Fluid LeakStudies 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
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Research Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057157
- Sponsor's protocol ID
- 17-10
- Status last verified
- Oct 2022
- First submitted
- 13 Aug 2019
- Last updated
- 14 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after final report has been distributed and ending 5 years after final report has been distributed. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Clinical Data Collection Plan for the Biodesign® Dural and Duraplasty Grafts
- ClinicalTrials.gov ID
- NCT04057157
- Acronym / sponsor ID
- 17-10
- Conditions
- Cerebrospinal Fluid Leak
- Keywords
- dura mater repair, cerebrospinal fluid leak, CSF leak, Biodesign® Dural Repair Graft, Biodesign® Duraplasty Repair Graft
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Cook Research IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 6 Jun 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 15 Aug 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.
The purpose of this clinical study is to gather post-market clinical evidence on the use of the Biodesign® Dural and Duraplasty Grafts when used as a dura substitute of the dura mater.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have had dura mater repair using a Biodesign Dural or Duraplasty Graft.
Key inclusion criteria (1 listed)
- 1. Planned use of the Biodesign Dural or Duraplasty Graft.
Key exclusion criteria (3 listed)
- Age <18 years
- Unable or unwilling to provide informed consent
- Life expectancy <6 months
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 |
|---|---|---|
| Biodesign Dural or Duraplasty Repair GraftsPatients will receive the Biodesign Dural or Duraplasty Repair Grafts according to the Instruction for Use. | Device | – |
Primary outcome
Percentage of patients without clinically relevant cerebrospinal fluid (CSF) leakage
Time frame: 2 months
Clinically relevant CSF leakage is when it requires treatment (e.g., lumbar drain or surgical repair) or leads to an infection of the central nervous system (e.g., meningitis).
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 14 Oct 2022.
- Individual participant dataSharing planned: Undecided. Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after final report has been distributed and ending 5 years after final report has been distributed. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrospinal Fluid Leak, run by Cook Research Incorporated at 3 sites in 3 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 1 inclusion and 3 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 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada, Italy. 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?
Percentage of patients without clinically relevant cerebrospinal fluid (CSF) leakage (time frame: 2 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 14 Oct 2022.