Cerebrospinal Fluid LeakNCT04923867
Suturable DuraGen™ PMCF Study
An observational study of Cerebrospinal Fluid Leak, run by Integra LifeSciences Corporation at 3 sites in United States.
Trial summary
The primary goal of this study is to retrospectively collect data on the safety and efficacy of Suturable DuraGen™. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebrospinal Fluid Leak
- What is being tested?
- Suturable DuraGen™
- Type of treatment
- Medical device
- How many people
- 106 participants
- Where
- 3 sitesUnited States
- Study dates
- 28 Apr 2021to 31 Jul 2024
- 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: Neurosurgery service in Hospital
Who may be able to join
- Subject is between 18 and 80 years of age
- Subject has undergone either a supratentorial, an infratentorial, or a spinal procedure with the use of Suturable DuraGen™ prior to trial initiation
- Availability of post-operative assessment results.
Who cannot join
- 1. There are no exclusionary criteria for this study population
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Baptist Medical Center
Jacksonville, Florida, 32207
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: A Multicenter, Retrospective, Post-Market Clinical Follow-Up Study to Evaluate the Performance and Safety of Suturable DuraGen™
The primary goal of this study is to retrospectively collect data on the safety and efficacy of Suturable DuraGen™.
Read the detailed description
This is a multicenter, non-randomized, non-interventional, retrospective Post-Market Clinical Follow-up (PMCF) study to evaluate the occurrence of post-operative cerebrospinal fluid (CSF) leaks within 30 days (and up to 90 days) after use of Suturable DuraGen™ for a supratentorial, infratentorial, or spinal procedure.
- Conditions
- Cerebrospinal Fluid Leak
- Being tested
- Suturable DuraGen™
- 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.
Suturable DuraGen™Device
Suturable DuraGen™ Dural Regeneration Matrix, an absorbable implant for repair of dural defects.
| Study group | Role | What they receive |
|---|---|---|
| Supratentorial Procedure Group | Subjects that have undergone a supratentorial procedure with the use of Suturable DuraGen™. Receives: Device: Suturable DuraGen™ | |
| Infratentorial Procedure Group | Subjects that have undergone a infratentorial procedure with the use of Suturable DuraGen™. Receives: Device: Suturable DuraGen™ | |
| Spinal Procedure Group | Subjects that have undergone a spinal procedure with the use of Suturable DuraGen™. Receives: Device: Suturable DuraGen™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Outcome
Occurrence of post-operative cerebrospinal fluid (CSF) leaks post-procedure
Measured: post-up to 90 days
Secondary outcomes (1)
Occurrence of Adverse Event
Adverse event that occurred between days 30-90 post-operatively
Measured: Between days 30-90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start28 Apr 2021
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integra LifeSciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Tummon, Study director, Integra LifeSciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923867
- Sponsor's protocol ID
- C-DGSUT-001
- Status last verified
- Apr 2025
- First submitted
- 7 Jun 2021
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Retrospective, Post-Market Clinical Follow-Up Study to Evaluate the Performance and Safety of Suturable DuraGen™
- ClinicalTrials.gov ID
- NCT04923867
- Acronym / sponsor ID
- C-DGSUT-001
- Conditions
- Cerebrospinal Fluid Leak
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 11 Jun 2021 (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 primary goal of this study is to retrospectively collect data on the safety and efficacy of Suturable DuraGen™.
Detailed description
This is a multicenter, non-randomized, non-interventional, retrospective Post-Market Clinical Follow-up (PMCF) study to evaluate the occurrence of post-operative cerebrospinal fluid (CSF) leaks within 30 days (and up to 90 days) after use of Suturable DuraGen™ for a supratentorial, infratentorial, or spinal procedure.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Supratentorial Procedure Group | – | Device: Suturable DuraGen™Subjects that have undergone a supratentorial procedure with the use of Suturable DuraGen™. |
| Infratentorial Procedure Group | – | Device: Suturable DuraGen™Subjects that have undergone a infratentorial procedure with the use of Suturable DuraGen™. |
| Spinal Procedure Group | – | Device: Suturable DuraGen™Subjects that have undergone a spinal procedure with the use of Suturable DuraGen™. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Neurosurgery service in Hospital
Key inclusion criteria (3 listed)
- Subject is between 18 and 80 years of age
- Subject has undergone either a supratentorial, an infratentorial, or a spinal procedure with the use of Suturable DuraGen™ prior to trial initiation
- Availability of post-operative assessment results.
Key exclusion criteria (1 listed)
- 1. There are no exclusionary criteria for this study population
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 |
|---|---|---|
| Suturable DuraGen™Suturable DuraGen™ Dural Regeneration Matrix, an absorbable implant for repair of dural defects. | Device | Infratentorial Procedure Group, Spinal Procedure Group, Supratentorial Procedure Group |
Primary outcome
Patient Outcome
Time frame: post-up to 90 days
Occurrence of post-operative cerebrospinal fluid (CSF) leaks post-procedure
1 secondary outcome
Occurrence of Adverse Event
Time frame: Between days 30-90
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 6 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Cerebrospinal Fluid Leak
Not yet recruiting
A Prospective, Randomized, Two-Arm, Controlled, Single-Blind, Multi-Center Study to Evaluate the Safety and Efficacy of ArtiFix® Dural Repair Sealant Graft in Cranial and Spine Surgery (NEOFIX Study)
CerebroSpinal Fluid (CSF) Leak, Dural Tear
Recruiting
Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery
Skull Base Neoplasms, Cerebrospinal Fluid Leakage
RecruitingObservational study
Immiseal™ Dural Sealant Post-Market Registry Study
Dural Defect, Cerebrospinal Fluid Leak
Recruiting
Conservative vs Interventional Management of Postsurgical CSF Pseudomeningocele
CSF Leak, CSF Pressure Increased
Recruiting
Evaluation of Internal Nasal Splint-Supported Free Graft Versus Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks
CSF Leak
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.
Andrew Tummon study director
Integra LifeSciences
3 sites in 1 country: 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 Integra LifeSciences Corporation at 3 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 3 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 6 Apr 2025. 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. 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?
Patient Outcome (time frame: post-up to 90 days). 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 6 Apr 2025; AzTrials last refreshed its copy on 27 Oct 2026.