Elective Cranial Procedures With Dural IncisionPhase 3NCT01158378
Safety and Effectiveness of the Adherus Dural Sealant System When Used as a Dural Sealant in Cranial Procedures
A Phase 3 study testing Adherus Dural Sealant in people with Elective Cranial Procedures With Dural Incision, run by HyperBranch Medical Technology, Inc at 17 sites in United States.
Trial summary
The purpose of the study is to demonstrate the safety and effectiveness of the Adherus Dural Sealant System when used as a dural sealant in conjunction with standard methods of dural repair in cranial procedures. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Elective Cranial Procedures With Dural Incision
- What is being tested?
- Adherus Dural Sealant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 17 sitesUnited States
- Study dates
- Jun 2010to Jan 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre-Operative Inclusion Criteria
- Subject is scheduled for an elective cranial procedure involving a dural incision using any of the following surgical locations/approaches (or combination): frontal, temporal, occipital, and parietal (i.e. supratentorial), and/or midline or lateral suboccipital (i.e. infratentorial.) Subject requires a procedure involving a Class 1/clean wound (uninfected surgical wound in which no inflammation is encountered)
- Intra-Operative Inclusion Criteria
- Subject's linear extent of durotomy is ≥2 cm
- Subject's dural margins from the edges of bony defect are ≥3 mm throughout
- Subject's CSF leak is present intra-operatively following completion of primary dural closure (with or without non-autologous duraplasty or autologous tissue), either spontaneously or upon Valsalva maneuver, at up to 20 cm H2O for up to five (5) seconds
Who cannot join
- Subject requires a procedure involving a translabyrinthine, transsphenoidal, transoral approach, or any procedure that penetrates the air sinus or mastoid air cells. Note: Superficial penetration of mastoid air cells is not an exclusion if cells are appropriately sealed (e.g. bone wax).
- Subject has a CSF shunt such as; ventriculo-peritoneal, ventriculo-pleural, ventriculo-atrial or lumbo-peritoneal shunts.
- Subject has an external ventricular or lumbar CSF drain that must be left in place after surgery.
- Subject has had radiation treatment to the surgical site, or standard fractionated radiation therapy is planned within ten days post index-procedure. (Note: stereotactic radiosurgery prior to the planned index procedure is not an exclusion criterion).
- Subject has a systemic infection or evidence of any infection near planned operative site.
- Intra-Operative Exclusion Criteria
- Subject has an Incidental finding that meets any pre-operative exclusion criterion listed above.
- Subject requires the intra-operative placement of a CSF diversion device (e.g. ventricular catheter, subdural catheter, lumbar drain, or other device designed to externally evacuate CSF) that will be left in place after the procedure. Note: Subgaleal drains used for acute post-operative management of the incision site are permitted.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Carolina Neurosurgery & Spine Associates
Charlotte, North Carolina, 28204
University of Virginia
Charlottesville, Virginia, 22903
Northwestern University
Chicago, Illinois, 60611
Rush University Medical Center
Chicago, Illinois, 60612
Mayfield Clinic
Cincinnati, Ohio, 45219
Wayne State University
Detroit, Michigan, 48201
Colorado Brain and Spine Institute/Swedish Medical Center
Englewood, Colorado, 80113
NorthShore University HealthSystem
Evanston, Illinois, 60201
Penn State University Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Borgess Research Institute
Kalamazoo, Michigan, 49048
West Virginia University
Morgantown, West Virginia, 26506-9183
Florida Hospital
Orlando, Florida, 32804
Saint Louis University
St Louis, Missouri, 63104
Stony Brook University Medical Center
Stony Brook, New York, 11794-8122
University of South Florida
Tampa, Florida, 33606
Oklahoma Spine and Brain Institute
Tulsa, Oklahoma, 74132
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157-1029
About this study
Official title: A Pivotal Clinical Trial Examining the Safety and Effectiveness of the Adherus Dural Sealant System When Used as a Dural Sealant in Cranial Procedures
The purpose of the study is to demonstrate the safety and effectiveness of the Adherus Dural Sealant System when used as a dural sealant in conjunction with standard methods of dural repair in cranial procedures.
Read the detailed description
After surgery on the head, the dura, a membrane that covers the brain, must be closed in order to prevent CSF from leaking outside of the dura. When CSF leaks outside the dura, this can increase the risk of infection, cause painful headaches or complications that may require another surgery to repair the leak. Typically, your study doctor will close the dura with sutures (surgical stitches) and sometimes a piece of muscle, fat, or other soft tissue taken from another place on your body. However, it is still possible that CSF will continue to leak through small suture holes even when all appropriate precautions have been taken.
Dural surgical sealants have been developed to assist surgeons in stopping CSF leaks when standard measures following brain surgery are not effective. Sometimes, the leak seals on its own and there is no need for a surgical sealant.
This study is for participants who have a CSF leak after standard measures are used to close the dura at the end of their surgery. The decision to use a surgical sealant will be made when your surgeon finds that after stitching and using standard measures to close the dura, there is still a leak.
However, if your surgeon finds a CSF leak after he or she applies the standard stitches and tissues, and you have signed this informed consent, then you will be randomized to receive one of two surgical sealants (Randomized means like a flip of the coin). You will be selected to receive either Adherus™ Surgical Sealant or DuraSeal™ Surgical Sealant and your post surgery progress will be evaluated during study visits and with study tests. Adherus™ Surgical Sealant is an investigational device that has been developed to stop CSF leaks. It is being studied to find if it is just as effective and safe as DuraSeal™.
Adherus™ is made of two components that form a gel when they are combined. The gel is applied after the study doctor closes the incision. The gel acts as a thin, elastic barrier intended to prevent CSF from leaking until the dura tissue has properly healed on its own. The gel is then absorbed by the body over several months and excreted or removed from the body through the urine. This is the second study of Adherus™ in people in the United States.
If you choose to participate, you will have screening tests to see if you qualify to enroll in the study. Not everyone who is screened for the study will be able to participate. The device you receive will be determined by a random selection process. Neither you nor study personnel or your doctor can decide which device you receive. You will not be told which device you received until study completion. In addition, if your study doctor does not use any sealant at the end of your surgery (you may not have any CSF leak or the study doctor decides to use another closure procedure) then your study participation will be complete.
If you choose to participate and have screening tests to qualify you to enroll in the study, your surgery will be performed according to the regular standard of care. If CSF leaks from your dura after it is stitched closed by your study doctor and you continue to meet study entry measures, then your study doctor will apply the assigned study treatment to try to stop the leak. After the surgery, you will be seen 4 times over the next 4 months. You will be in the study for up to 5 months.
- Being tested
- Adherus Dural Sealant
- Keywords
- Adherus Dural Sealant, Adherus AutoSpray Dural Sealant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adherus Dural SealantDevice
In situ polymerizing sealant
| Study group | Role | What they receive |
|---|---|---|
| DuraSeal Dural Sealant System | Active comparator | Not described Receives: Device: Adherus Dural Sealant |
| Adherus Dural Sealant System | Experimental | Not described Receives: Device: Adherus Dural Sealant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Treated Subjects Who Were Free of Intra-operative Cerebrospinal Fluid (CSF) Leakage From Dural Repair During Valsalva Maneuver, CSF Leak / Pseudomeningocele, and Unplanned Retreatment of the Original Surgical Site
The primary endpoint was a composite evaluation of the safety and effectiveness of Adherus for a cranial application. The endpoint was measured by the proportion of treated subjects who were free of all of the following incidences:
- Intra-operative CSF leakage from dural repair after up to two Adherus / control applications during Valsalva maneuver up to 20cm H2O for up to 5 seconds.
- CSF leak or pseudomeningocele diagnosed by physical examination, biochemical assay or imaging study during the 120-day follow-up period of the index procedure
- Unplanned retreatment of the original surgical site adjudicated by the CEC to be device-related, including meningitis or the management of deep infection, minimally invasive procedures or return to the operating room for neurosurgical complications other than CSF leak or pseudomeningocele formation or those related to the subject's pre-existing condition, during the 120-day follow-up period.
Measured: 120 days
Secondary outcomes (1)
Proportion of Subjects Free of Device-related Surgical Wound Infections or Meningitis During 120-day Follow-up.
Device-related surgical wound infections included all infections classified by the CEC as definitely, probably, possibly or undetermined in relation to the device.
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elective Cranial Procedures With Dural IncisionStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- HyperBranch Medical Technology, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Smith, MD, Principal investigator, Carolina Neurosurgery & Spine Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158378
- Sponsor's protocol ID
- HBMT-080453
- Status last verified
- Feb 2014
- First submitted
- 6 Jul 2010
- Last updated
- 8 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Bakar B, Kose EA, Balci M, Atasoy P, Sarkarati B, Alhan A, Kilinc K, Keskil IS. Evaluation of the neurotoxicity of the polyethylene glycol hydrogel dural sealant. Turk Neurosurg. 2013;23(1):16-24. doi: 10.5137/1019-5149.JTN.6039-12.1.
PubMed 23344862
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal Clinical Trial Examining the Safety and Effectiveness of the Adherus Dural Sealant System When Used as a Dural Sealant in Cranial Procedures
- ClinicalTrials.gov ID
- NCT01158378
- Acronym / sponsor ID
- HBMT-080453
- Keywords
- Adherus Dural Sealant, Adherus AutoSpray Dural Sealant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- HyperBranch Medical Technology, IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 8 Jul 2010 (estimated)
- Results
- Posted 8 Apr 2014
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 the study is to demonstrate the safety and effectiveness of the Adherus Dural Sealant System when used as a dural sealant in conjunction with standard methods of dural repair in cranial procedures.
Detailed description
After surgery on the head, the dura, a membrane that covers the brain, must be closed in order to prevent CSF from leaking outside of the dura. When CSF leaks outside the dura, this can increase the risk of infection, cause painful headaches or complications that may require another surgery to repair the leak. Typically, your study doctor will close the dura with sutures (surgical stitches) and sometimes a piece of muscle, fat, or other soft tissue taken from another place on your body. However, it is still possible that CSF will continue to leak through small suture holes even when all appropriate precautions have been taken.
Dural surgical sealants have been developed to assist surgeons in stopping CSF leaks when standard measures following brain surgery are not effective. Sometimes, the leak seals on its own and there is no need for a surgical sealant.
This study is for participants who have a CSF leak after standard measures are used to close the dura at the end of their surgery. The decision to use a surgical sealant will be made when your surgeon finds that after stitching and using standard measures to close the dura, there is still a leak.
However, if your surgeon finds a CSF leak after he or she applies the standard stitches and tissues, and you have signed this informed consent, then you will be randomized to receive one of two surgical sealants (Randomized means like a flip of the coin). You will be selected to receive either Adherus™ Surgical Sealant or DuraSeal™ Surgical Sealant and your post surgery progress will be evaluated during study visits and with study tests. Adherus™ Surgical Sealant is an investigational device that has been developed to stop CSF leaks. It is being studied to find if it is just as effective and safe as DuraSeal™.
Adherus™ is made of two components that form a gel when they are combined. The gel is applied after the study doctor closes the incision. The gel acts as a thin, elastic barrier intended to prevent CSF from leaking until the dura tissue has properly healed on its own. The gel is then absorbed by the body over several months and excreted or removed from the body through the urine. This is the second study of Adherus™ in people in the United States.
If you choose to participate, you will have screening tests to see if you qualify to enroll in the study. Not everyone who is screened for the study will be able to participate. The device you receive will be determined by a random selection process. Neither you nor study personnel or your doctor can decide which device you receive. You will not be told which device you received until study completion. In addition, if your study doctor does not use any sealant at the end of your surgery (you may not have any CSF leak or the study doctor decides to use another closure procedure) then your study participation will be complete.
If you choose to participate and have screening tests to qualify you to enroll in the study, your surgery will be performed according to the regular standard of care. If CSF leaks from your dura after it is stitched closed by your study doctor and you continue to meet study entry measures, then your study doctor will apply the assigned study treatment to try to stop the leak. After the surgery, you will be seen 4 times over the next 4 months. You will be in the study for up to 5 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DuraSeal Dural Sealant System | Active comparator | Device: Adherus Dural Sealant |
| Adherus Dural Sealant System | Experimental | Device: Adherus Dural Sealant |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pre-Operative Inclusion Criteria
- Subject is scheduled for an elective cranial procedure involving a dural incision using any of the following surgical locations/approaches (or combination): frontal, temporal, occipital, and parietal (i.e. supratentorial), and/or midline or lateral suboccipital (i.e. infratentorial.) Subject requires a procedure involving a Class 1/clean wound (uninfected surgical wound in which no inflammation is encountered)
- Intra-Operative Inclusion Criteria
- Subject's linear extent of durotomy is ≥2 cm
- Subject's dural margins from the edges of bony defect are ≥3 mm throughout
Key exclusion criteria (8 listed)
- Subject requires a procedure involving a translabyrinthine, transsphenoidal, transoral approach, or any procedure that penetrates the air sinus or mastoid air cells. Note: Superficial penetration of mastoid air cells is not an exclusion if cells are appropriately sealed (e.g. bone wax).
- Subject has a CSF shunt such as; ventriculo-peritoneal, ventriculo-pleural, ventriculo-atrial or lumbo-peritoneal shunts.
- Subject has an external ventricular or lumbar CSF drain that must be left in place after surgery.
- Subject has had radiation treatment to the surgical site, or standard fractionated radiation therapy is planned within ten days post index-procedure. (Note: stereotactic radiosurgery prior to the planned index procedure is not an exclusion criterion).
- Subject has a systemic infection or evidence of any infection near planned operative site.
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 |
|---|---|---|
| Adherus Dural SealantIn situ polymerizing sealant | Device | Adherus Dural Sealant System, DuraSeal Dural Sealant System |
Primary outcome
Proportion of Treated Subjects Who Were Free of Intra-operative Cerebrospinal Fluid (CSF) Leakage From Dural Repair During Valsalva Maneuver, CSF Leak / Pseudomeningocele, and Unplanned Retreatment of the Original Surgical Site
Time frame: 120 days
The primary endpoint was a composite evaluation of the safety and effectiveness of Adherus for a cranial application. The endpoint was measured by the proportion of treated subjects who were free of all of the following incidences: * Intra-operative CSF leakage from dural repair after up to two Adherus / control applications during Valsalva maneuver up to 20cm H2O for up to 5 seconds. * CSF leak or pseudomeningocele diagnosed by physical examination, biochemical assay or imaging study during the 120-day follow-up period of the index procedure * Unplanned retreatment of the original surgical site adjudicated by the CEC to be device-related, including meningitis or the management of deep infection, minimally invasive procedures or return to the operating room for neurosurgical complications other than CSF leak or pseudomeningocele formation or those related to the subject's pre-existing condition, during the 120-day follow-up period.
1 secondary outcome
Proportion of Subjects Free of Device-related Surgical Wound Infections or Meningitis During 120-day Follow-up.
Time frame: 120 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23344862Bakar B, Kose EA, Balci M, Atasoy P, Sarkarati B, Alhan A, Kilinc K, Keskil IS. Evaluation of the neurotoxicity of the polyethylene glycol hydrogel dural sealant. Turk Neurosurg. 2013;23(1):16-24. doi: 10.5137/1019-5149.JTN.6039-12.1.
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.
Mark Smith, MD principal investigator
Carolina Neurosurgery & Spine Associates
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adherus Dural Sealant in people with Elective Cranial Procedures With Dural Incision, run by HyperBranch Medical Technology, Inc at 17 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 6 inclusion and 8 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 8 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Treated Subjects Who Were Free of Intra-operative Cerebrospinal Fluid (CSF) Leakage From Dural Repair During Valsalva Maneuver, CSF Leak / Pseudomeningocele, and Unplanned Retreatment of the Original Surgical Site (time frame: 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01158378, which also lists 1 linked publication.
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 8 Apr 2014.