Spinal DuraplastyNCT04498026
Adherus™ Dural Sealant in Spinal Procedures
A study testing Adherus Dural Sealant System and DuraSeal Exact Dural Sealant System in people with Spinal Duraplasty, run by Stryker Craniomaxillofacial at 14 sites in United States.
Trial summary
The purpose of this study is to test an experimental device, the Adherus AutoSpray and Adherus AutoSpray ET Dural Sealant, in spinal surgical procedures. This study is being done to compare Adherus AutoSpray and Adherus AutoSpray ET Dural Sealant to DuraSeal Exact Spinal Sealant, which has already received Federal… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Duraplasty
- What is being tested?
- Adherus Dural Sealant System and DuraSeal Exact Dural Sealant System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 14 sitesUnited States
- Study dates
- 19 Nov 2020to 29 Aug 2025
- Phase
- Interventional
- 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
- Subject is ≥ 18 and ≤ 75 years old.
- Subject is scheduled for an elective spinal procedure that will require a planned durotomy.
- Subject requires a procedure involving a Class I/clean wound (uninfected surgical wound in which no inflammation is encountered).
- Subject is able and willing to provide informed consent and HIPAA authorization.
- Subject is able and willing to meet all study requirements, including attending all post-index procedure assessment visits and radiological tests.
- Intra-Operative Inclusion Criteria:
- Subject has durotomy edges that can be re-approximated using the investigator's standard methods of dural repair.
Who cannot join
- Subject has clinically significant hydrocephalus or clinical evidence of altered CSF dynamics.
- Subject has a pre-existing external lumbar CSF drain or internal CSF shunt.
- Subject has experienced previous CSF leak (secondary to trauma, neoplasm, surgery, or other etiology).
- Subject is undergoing a Chiari malformation procedure.
- Subject has undergone a previous spinal procedure in the same anatomical location.
- Subject has had radiation treatment to the surgical site, or standard fractionated radiation therapy is planned within ten days post indexprocedure.
Show all 26Show fewer
- Subject has spinal metallic implants that may cause significant imaging artifact on the MRI evaluation of the spine.
- Subject has metallic implant(s) that are not MRI compatible, e.g., cochlear implant, neurostimulator, stent, surgical clip, cardiac pacemakers, or other non-MRI compatible implants, or an elective implant of such devices is planned during the course of the study. Note: mercury amalgam dental fillings or similar metallic dental prostheses are not an exclusion criterion.
- Subject has a known malignancy or another condition with anticipated survival shorter than six months.
- Subject has undergone chemotherapy treatment, excluding hormonal therapy, within three weeks prior to the planned index procedure, or chemotherapy treatment is planned within two weeks after the index procedure is performed.
- Subject has been treated with chronic steroid therapy (defined as regular (daily) administration of steroid agent(s) for ≥ 8 weeks) unless discontinued greater than four weeks prior to the planned index procedure. Note: standard acute perioperative steroids are permitted; administration of steroid agents for < 8 weeks duration prior to the planned index procedure is permitted.
- Subject has received warfarin, heparin, other anticoagulant agents, aspirin or non steroid anti-inflammatory agents on a daily basis and pre-surgical, standard of care drug wash-out did not occur.
- Subject has a compromised immune system or autoimmune disease or is on chronic immunosuppressant agents at baseline.
- Subject has a systemic infection or evidence of any infection near planned operative site.
- Subject has a serum creatinine level > 2.0 mg/dL.
- Subject has a serum total bilirubin > 2.5 mg/dL at baseline.
- Subject has uncontrolled diabetes as evidenced by an HbA1c > 7% prior to surgery.
- Subject has a known allergy to FD\&C Blue #1 and/or FD\&C Yellow #5 or any of the constituents of the dural sealants.
- Subject is pregnant, breast-feeding, or intends to become pregnant during the course of the study.
- Subject is participating in a clinical trial of another investigational drug or device and has not completed the required follow-up period.
- Intra-Operative Exclusion Criteria:
- Subject has an incidental finding that meets any pre-operative exclusion criterion listed above.
- Subject's dural defect cannot be closed with suture and/or duraplasty material.
- Subject has a gap > 2 mm present between dural edges, or between the edge of dura and duraplasty material, based on visual estimate by surgeon before application of the surgical sealant.
- Subject had undergone laminoplasty decompression.
- Subject had undergone a syringomyelia procedure where the shunt is not placed in the subarachnoid position.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Carolina Neurosurgery & Spine Associates
Charlotte, North Carolina, 28204
Rush University Medical Center
Chicago, Illinois, 60612
University of Illinois at Chicago
Chicago, Illinois, 60612
City of Hope National Medical Center
Duarte, California, 91010
Duke University
Durham, North Carolina, 27705
Houston Methodist Research Institute
Houston, Texas, 77030
University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
Mayo Clinic (FL)
Jacksonville, Florida, 32224
Columbia University Irving Medical Center
New York, New York, 10032
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Carilion Clinic
Roanoke, Virginia, 24014
Mayo Clinic
Rochester, Minnesota, 55902
University of California Davis Health
Sacramento, California, 95817
Stanford University
Stanford, California, 94305
About this study
Official title: A Pivotal Clinical Trial Evaluating the Safety and Effectiveness of Adherus™ AutoSpray and Adherus™ AutoSpray ET Dural Sealant When Used as a Dural Sealant in Spinal Procedures
The purpose of this study is to test an experimental device, the Adherus AutoSpray and Adherus AutoSpray ET Dural Sealant, in spinal surgical procedures.
This study is being done to compare Adherus AutoSpray and Adherus AutoSpray ET Dural Sealant to DuraSeal Exact Spinal Sealant, which has already received Federal Food and Drug Administration (FDA) approval in spinal procedures.
Read the detailed description
This is a prospective, randomized, controlled, single-blind, multicenter, pivotal trial that will evaluate the safety and effectiveness of Adherus Dural Sealant when used in conjunction with standard methods of dural repair in spinal procedures. This trial uses the commercially available DuraSeal Exact as an active control. The trial is designed to demonstrate non-inferiority of Adherus Dural Sealant to DuraSeal Exact.
Subjects who are undergoing spinal surgery, consent to participate in this trial and experience a durotomy will be considered for study enrollment. Following a two-tiered inclusion/exclusion consideration, subjects will be randomized intraoperatively using a 1:1 randomization ratio. Up to 90 subjects will be randomized to treatment with either Adherus Dural Sealant or DuraSeal Exact with at least 50% of subjects undergoing procedures at lumbar or lumbosacral levels. Up to 30 investigational sites within the United States will participate in this trial.
A primary composite endpoint evaluating safety and effectiveness will be measured within a 90-day required follow-up period post-procedure. Subjects will be followed at discharge or between postoperative days (POD) 1-4 from the index procedure (whichever occurs first) and at 30 days and 90 days post-index procedure.
- Conditions
- Spinal Duraplasty
- Being tested
- Adherus Dural Sealant System, DuraSeal Exact Dural Sealant System
- Keywords
- Adherus Dural Sealant, Adherus AutoSpray Dural Sealant, Dura mater, Durotomy, CSF leak
- Medical subject headings
- Cerebrospinal Fluid Otorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adherus Dural Sealant SystemDevice
Adherus Dural Sealant, In situ polymerizing sealant
DuraSeal Exact Dural Sealant SystemDevice
DuraSeal Exact (P080013b)
| Study group | Role | What they receive |
|---|---|---|
| Adherus Dural Sealant System | Experimental | Device: Adherus Dural Sealant, In situ polymerizing sealant Receives: Device: Adherus Dural Sealant System |
| DuraSeal Exact Dural Sealant System | Active comparator | Device: DuraSeal Exact (P080013b) Receives: Device: DuraSeal Exact Dural Sealant System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Endpoint Was the Success Rate Defined as Freedom From the Following Events:
- CSF leak or pseudomeningocele diagnosed by physical examination, biochemical assay or imaging through 90-day following the index procedure.
- Unplanned retreatment of the original surgical site, adjudicated as device related by the CEC, other than CSF leak or pseudomeningocele formation or those related to the subject's pre-existing condition, through 90-day following the index procedure including:
- treatment for deep infection
- treatment for meningitis
- minimally invasive procedures or return to the operating room for neurosurgical complications
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start19 Nov 2020
- Primary completion29 Aug 2025
- Study completion29 Aug 2025
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.
- Other trials for Spinal DuraplastyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stryker Craniomaxillofacial
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fortrea
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498026
- Sponsor's protocol ID
- HBMT-US-2019-001
- Status last verified
- Sep 2026
- First submitted
- 30 Jul 2020
- Last updated
- 22 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal Clinical Trial Evaluating the Safety and Effectiveness of Adherus™ AutoSpray and Adherus™ AutoSpray ET Dural Sealant When Used as a Dural Sealant in Spinal Procedures
- ClinicalTrials.gov ID
- NCT04498026
- Acronym / sponsor ID
- HBMT-US-2019-001
- Conditions
- Spinal Duraplasty
- Keywords
- Adherus Dural Sealant, Adherus AutoSpray Dural Sealant, Dura mater, Durotomy, CSF leak
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Stryker CraniomaxillofacialIndustry (pharma, biotech, devices)
- Collaborators
- Fortrea
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- 29 Aug 2025 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 4 Aug 2020 (actual)
- Results
- Posted 22 Oct 2026
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 study is to test an experimental device, the Adherus AutoSpray and Adherus AutoSpray ET Dural Sealant, in spinal surgical procedures.
This study is being done to compare Adherus AutoSpray and Adherus AutoSpray ET Dural Sealant to DuraSeal Exact Spinal Sealant, which has already received Federal Food and Drug Administration (FDA) approval in spinal procedures.
Detailed description
This is a prospective, randomized, controlled, single-blind, multicenter, pivotal trial that will evaluate the safety and effectiveness of Adherus Dural Sealant when used in conjunction with standard methods of dural repair in spinal procedures. This trial uses the commercially available DuraSeal Exact as an active control. The trial is designed to demonstrate non-inferiority of Adherus Dural Sealant to DuraSeal Exact.
Subjects who are undergoing spinal surgery, consent to participate in this trial and experience a durotomy will be considered for study enrollment. Following a two-tiered inclusion/exclusion consideration, subjects will be randomized intraoperatively using a 1:1 randomization ratio. Up to 90 subjects will be randomized to treatment with either Adherus Dural Sealant or DuraSeal Exact with at least 50% of subjects undergoing procedures at lumbar or lumbosacral levels. Up to 30 investigational sites within the United States will participate in this trial.
A primary composite endpoint evaluating safety and effectiveness will be measured within a 90-day required follow-up period post-procedure. Subjects will be followed at discharge or between postoperative days (POD) 1-4 from the index procedure (whichever occurs first) and at 30 days and 90 days post-index procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adherus Dural Sealant System | Experimental | Device: Adherus Dural Sealant SystemDevice: Adherus Dural Sealant, In situ polymerizing sealant |
| DuraSeal Exact Dural Sealant System | Active comparator | Device: DuraSeal Exact Dural Sealant SystemDevice: DuraSeal Exact (P080013b) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject is ≥ 18 and ≤ 75 years old.
- Subject is scheduled for an elective spinal procedure that will require a planned durotomy.
- Subject requires a procedure involving a Class I/clean wound (uninfected surgical wound in which no inflammation is encountered).
- Subject is able and willing to provide informed consent and HIPAA authorization.
- Subject is able and willing to meet all study requirements, including attending all post-index procedure assessment visits and radiological tests.
Key exclusion criteria (26 listed)
- Subject has clinically significant hydrocephalus or clinical evidence of altered CSF dynamics.
- Subject has a pre-existing external lumbar CSF drain or internal CSF shunt.
- Subject has experienced previous CSF leak (secondary to trauma, neoplasm, surgery, or other etiology).
- Subject is undergoing a Chiari malformation procedure.
- Subject has undergone a previous spinal procedure in the same anatomical location.
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 Sealant SystemAdherus Dural Sealant, In situ polymerizing sealant | Device | Adherus Dural Sealant System |
| DuraSeal Exact Dural Sealant SystemDuraSeal Exact (P080013b) | Device | DuraSeal Exact Dural Sealant System |
Primary outcome
The Primary Endpoint Was the Success Rate Defined as Freedom From the Following Events:
Time frame: 90 Days
* CSF leak or pseudomeningocele diagnosed by physical examination, biochemical assay or imaging through 90-day following the index procedure. * Unplanned retreatment of the original surgical site, adjudicated as device related by the CEC, other than CSF leak or pseudomeningocele formation or those related to the subject's pre-existing condition, through 90-day following the index procedure including: * treatment for deep infection * treatment for meningitis * minimally invasive procedures or return to the operating room for neurosurgical complications
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Spinal Duraplasty
Active, not recruitingObservational study
MiDura-Study (Neuro-Patch in Duraplasty)
Meningioma, Tumor, Brain
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.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adherus Dural Sealant System and DuraSeal Exact Dural Sealant System in people with Spinal Duraplasty, run by Stryker Craniomaxillofacial at 14 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 26 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 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
Yes. Results are posted in the registry (first posted 22 Oct 2026). 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?
The Primary Endpoint Was the Success Rate Defined as Freedom From the Following Events: (time frame: 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 22 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.