Dural SealingDuraSeal PASNCT01410864
DuraSeal Exact Spine Sealant System Post-Approval Study
An observational study of Dural Sealing, run by Integra LifeSciences Corporation at 36 sites in United States.
Trial summary
This is a non-randomized, post-approval study to further evaluate the rate of post-operative Cerebral Spinal Fluid (CSF) leaks in subjects who undergo a spinal procedure and receive DuraSeal Exact Spine Sealant System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dural Sealing
- What is being tested?
- DuraSeal Exact Spine Sealant System
- Type of treatment
- Medical device
- How many people
- 924 participants
- Where
- 36 sitesUnited States
- Study dates
- Aug 2011to Jul 2016
- 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: DuraSeal group will be patients that undergo a spinal procedure where a dural opening occurrs and is treated with DuraSeal Exact Spine Sealant System. Control group will be patients that have undergone a spinal procedure where a dural opening occurred and was treated with anything other than DuraSeal Sealant (Spine or Dural). These subjects may be enrolled retrospectively (through a chart review of past cases) or prospectively.
Who may be able to join
- Subject is 18 years of age or older
- Subject had a spinal procedure where a dural opening (either intentional or incidental) occurred and was treated with either:
- DuraSeal™ Exact Spine Sealant (DuraSeal™ Sealant group ONLY) OR
- Any other method of sealing the dura with the exception of DuraSeal™ Sealant -either spinal or cranial. (Control group ONLY)
- Subject, or authorized representative, has been informed of the nature of the study and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) of the respective clinical site prior to the collection of study data.
- Prospective subjects: Consent must be obtained within 24 hours of surgery stop time.
- Retrospective subjects (Control group specific): IRB approval may be granted to individual sites to waive requirement for informed consent.
Who cannot join
- The investigator determines that the subject will not be able to comply with the required follow-up visits (not required if subject is being enrolled retrospectively- control group ONLY)
- Pregnant or breastfeeding females (as documented in the medical records; no testing beyond the site's standard of care is required)
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
Study site
Atlanta, Georgia, 30303
Study site
Baltimore, Maryland, 21211
Study site
Bend, Oregon, 97701
Study site
Boston, Massachusetts, 02120
Study site
Boulder, Colorado, 80302
Study site
Charleston, South Carolina, 29406
Study site
Charlotte, North Carolina, 28207
Study site
Charlottesville, Virginia, 22903
Study site
Chicago, Illinois, 60611
Study site
Cincinnati, Ohio, 45219
Study site
Cleveland, Ohio, 44106
Study site
Colorado Springs, Colorado, 80907
Study site
Columbus, Ohio, 43210
Study site
Denver, Colorado, 80045
Study site
Durham, North Carolina, 27708
Study site
East Syracuse, New York, 13057
Study site
Kansas City, Kansas, 66160
Study site
Lebanon, New Hampshire, 03766
Study site
Los Angeles, California, 90033
Study site
Louisville, Kentucky, 40295
Study site
New Orleans, Louisiana, 70121
Study site
Philadelphia, Pennsylvania, 19140
Study site
Phoenix, Arizona, 85023
Study site
Pittsburgh, Pennsylvania, 15212
Study site
Pittsburgh, Pennsylvania, 15213
Study site
Plano, Texas, 75093
Study site
Royal Oak, Michigan, 48073
Study site
Sacramento, California, 95616
Study site
San Francisco, California, 94143
Study site
San Jose, California, 95128
Study site
Seattle, Washington, 98122
Study site
St Louis, Missouri, 63130
Study site
Stanford, California, 94305
Study site
Tampa, Florida, 33606
Study site
Tampa, Florida, 33637
Study site
Washington D.C., District of Columbia, 20037
About this study
This is a non-randomized, post-approval study to further evaluate the rate of post-operative Cerebral Spinal Fluid (CSF) leaks in subjects who undergo a spinal procedure and receive DuraSeal Exact Spine Sealant System.
- Conditions
- Dural Sealing
- Being tested
- DuraSeal Exact Spine Sealant System, Control
- Keywords
- cerebrospinal fluid leaks, dural opening, dural sealing
- Medical subject headings
- Cerebrospinal Fluid Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuraSeal Exact Spine Sealant SystemDevice
DuraSeal Exact Spine Sealant System will be administered to those eligible patients, to treat a dural opening.
ControlOther
Devices or drugs used to seal the dura (other than DuraSeal)
| Study group | Role | What they receive |
|---|---|---|
| DuraSeal Arm | Prospective enrollment of subjects who have received DuraSeal Exact Spinal Sealant System for treatment of an intentional or incidental dural tear during spine surgery. Receives: Device: DuraSeal Exact Spine Sealant System | |
| Control Arm | Subjects who have undergone a spinal procedure where techniques other than DuraSeal were administered for the treatment of either an intentional or incidental opening of the dura may be enrolled either prospectively or retrospectively (via medical record screening) Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative CSF leaks
Measured: 90 days post-operative
Secondary outcomes (2)
Post-operative surgical site infections
Deep surgical site infections as defined by the Center for Disease Control criteria.
Measured: 90 days post-operative
Post-operative neurological serious adverse events
Measured: 90 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dural SealingStudies 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
- Other
- Enrolment
- 924 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410864
- Sponsor's protocol ID
- COVDRSS0002
- Acronym
- DuraSeal PAS
- Status last verified
- Feb 2017
- First submitted
- 4 Aug 2011
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DuraSeal Exact Spine Sealant System Post-Approval Study
- ClinicalTrials.gov ID
- NCT01410864
- Acronym / sponsor ID
- DuraSeal PAS / COVDRSS0002
- Conditions
- Dural Sealing
- Keywords
- cerebrospinal fluid leaks, dural opening, dural sealing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 924 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 5 Aug 2011 (estimated)
- 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.
This is a non-randomized, post-approval study to further evaluate the rate of post-operative Cerebral Spinal Fluid (CSF) leaks in subjects who undergo a spinal procedure and receive DuraSeal Exact Spine Sealant System.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DuraSeal Arm | – | Device: DuraSeal Exact Spine Sealant SystemProspective enrollment of subjects who have received DuraSeal Exact Spinal Sealant System for treatment of an intentional or incidental dural tear during spine surgery. |
| Control Arm | – | Other: ControlSubjects who have undergone a spinal procedure where techniques other than DuraSeal were administered for the treatment of either an intentional or incidental opening of the dura may be enrolled either prospectively or retrospectively (via medical record screening) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- DuraSeal group will be patients that undergo a spinal procedure where a dural opening occurrs and is treated with DuraSeal Exact Spine Sealant System. Control group will be patients that have undergone a spinal procedure where a dural opening occurred and was treated with anything other than DuraSeal Sealant (Spine or Dural). These subjects may be enrolled retrospectively (through a chart review of past cases) or prospectively.
Key inclusion criteria (7 listed)
- Subject is 18 years of age or older
- Subject had a spinal procedure where a dural opening (either intentional or incidental) occurred and was treated with either:
- Subject, or authorized representative, has been informed of the nature of the study and has provided written informed consent approved by the appropriate Institutional Review Board (IRB) of the respective clinical site prior to the collection of study data.
Key exclusion criteria (2 listed)
- The investigator determines that the subject will not be able to comply with the required follow-up visits (not required if subject is being enrolled retrospectively- control group ONLY)
- Pregnant or breastfeeding females (as documented in the medical records; no testing beyond the site's standard of care is required)
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 |
|---|---|---|
| DuraSeal Exact Spine Sealant SystemDuraSeal Exact Spine Sealant System will be administered to those eligible patients, to treat a dural opening. | Device | DuraSeal Arm |
| ControlDevices or drugs used to seal the dura (other than DuraSeal) | Other | Control Arm |
Primary outcome
Post-operative CSF leaks
Time frame: 90 days post-operative
2 secondary outcomes
Post-operative surgical site infections
Time frame: 90 days post-operative
Post-operative neurological serious adverse events
Time frame: 90 days post-operative
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 1 Mar 2017.
Related trials for Dural Sealing
RecruitingPhase 4
CraniSeal Post Approval Study
Leak, Cerebrospinal Fluid
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.
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dural Sealing, run by Integra LifeSciences Corporation at 36 sites in United States.
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 7 inclusion and 2 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 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States. 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?
Post-operative CSF leaks (time frame: 90 days post-operative). 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 1 Mar 2017.