An interventional study of Adherus Dural Sealant System and DuraSeal Exact Dural Sealant System in Spinal Duraplasty, sponsored by Stryker Craniomaxillofacial. Completed at 14 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Stryker Craniomaxillofacial (part of Stryker) · Not applicable, Interventional, and Treatment
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.
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.
Stryker Craniomaxillofacial is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Subject is participating in a clinical trial of another drug or device and has not completed the required follow-up period.
Intra-Operative Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Adherus Dural Sealant, In situ polymerizing sealant
Device: Adherus Dural Sealant System
Device: DuraSeal Exact (P080013b)
Device: DuraSeal Exact Dural Sealant System
Adherus Dural Sealant, In situ polymerizing sealant
DuraSeal Exact (P080013b)
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
Time frame: 90 Days
The first subject first visit occurred November 19, 2020, and the last subject last visit occurred on April 17, 2025.
| Milestone | Adherus Dural Sealant (Test Group) | DuraSeal Exact (Control Group) |
|---|---|---|
| Started | 50 | 44 |
| Completed | 44 | 39 |
| Not completed | 6 | 5 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Withdrawal by subject | 2 | 2 |
| Withdrew: Other | 2 | 1 |
| Withdrew: Physician decision | 0 | 1 |
* 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
| percentage of participants | Adherus Dural Sealant (Test Group) | DuraSeal Exact (Control Group) |
|---|---|---|
| The Primary Endpoint Was the Success Rate Defined as Freedom From the Following Events: | 95.5 (84.5 to 99.4) | 92.1 (78.6 to 98.3) |
Collected over Overall Incidence of AEs by Seriousness and Relation through 90 days (all enrolled population). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adherus Dural Sealant (Test Group) | 1/50 (2%) | 10/50 (20%) | 20/50 (40%) |
| DuraSeal Exact (Control Group) | 0/44 (0%) | 7/44 (15.9%) | 24/44 (54.5%) |
| Event | Adherus Dural Sealant (Test Group) | DuraSeal Exact (Control Group) |
|---|---|---|
| OtherGeneral disorders | 8/50 | 7/44 |
| InfectionInfections and infestations | 2/50 | 3/44 |
| PseudomeningoceleNervous system disorders | 1/50 | 3/44 |
| DeathGeneral disorders | 1/50 | 0/44 |
| CSF LeakNervous system disorders | 0/50 | 0/44 |
| Retreatment of surgical siteGeneral disorders | 0/50 | 0/44 |
| Event | Adherus Dural Sealant (Test Group) | DuraSeal Exact (Control Group) |
|---|---|---|
| Pain - BackMusculoskeletal and connective tissue disorders | 3/50 | 8/44 |
| Weakness - Lower ExtremityMusculoskeletal and connective tissue disorders | 3/50 | 5/44 |
| Paresthesia - Lower ExtremityNervous system disorders | 3/50 | 4/44 |
| IncontinenceGeneral disorders | 3/50 | 4/44 |
| Swelling - Upper ExtremityVascular disorders | 1/50 | 4/44 |
| Pain - Lower ExtremityMusculoskeletal and connective tissue disorders | 4/50 | 0/44 |
| Pain - AbdominalGastrointestinal disorders | 4/50 | 2/44 |
| Urinary Tract Infection (UTI)General disorders | 4/50 | 2/44 |
| Swelling - Lower ExtremityVascular disorders | 3/50 | 3/44 |
| PseudomeningoceleNervous system disorders | 1/50 | 3/44 |
The demographics and baseline characteristics of the enrolled population are typical for a dural sealant study performed in the US.
| Age, Continuous(years) | Adherus Dural Sealant (Test Group) | DuraSeal Exact (Control Group) | Total |
|---|---|---|---|
| Median | 54.1 (24.1 to 70.7) | 61.6 (30.6 to 73.9) | 58.5 (24.1 to 73.9) |
| Sex: Female, Male(Participants) | Adherus Dural Sealant (Test Group) | DuraSeal Exact (Control Group) | Total |
|---|---|---|---|
| Female | 28 | 19 | 47 |
| Male | 22 | 25 | 47 |
| Ethnicity (NIH/OMB)(Participants) | Adherus Dural Sealant (Test Group) | DuraSeal Exact (Control Group) | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 4 | 10 |
| Not Hispanic or Latino | 41 | 38 | 79 |
| Unknown or Not Reported | 3 | 2 | 5 |
| Race/Ethnicity, Customized(participants (not mutually exclusive)) | Adherus Dural Sealant (Test Group) | DuraSeal Exact (Control Group) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 4 | 2 | 6 |
| Black or African American | 1 | 5 | 6 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| White | 40 | 32 | 72 |
| Other | 3 | 2 | 5 |
| Unknown or Not Reported | 4 | 3 | 7 |
| Primary Indication for Surgery(Participants) | Adherus Dural Sealant (Test Group) | DuraSeal Exact (Control Group) | Total |
|---|---|---|---|
| Intradural Tumor | 41 | 32 | 73 |
| Intradural Lesion | 5 | 6 | 11 |
| Tethered Cord | 0 | 1 | 1 |
| Vascular Malformations | 0 | 3 | 3 |
| Arachnoid Cysts | 2 | 1 | 3 |
| Syringomyelia | 0 | 0 | 0 |
| Other | 2 | 1 | 3 |
| Anatomical Location(participants) | Adherus Dural Sealant (Test Group) | DuraSeal Exact (Control Group) | Total |
|---|---|---|---|
| Lumbar or Lumbosacral | 22 | 18 | 40 |
| Cervical or Thoracic | 28 | 26 | 54 |
| Approach(Participants) | Adherus Dural Sealant (Test Group) | DuraSeal Exact (Control Group) | Total |
|---|---|---|---|
| Anterior | 1 | 1 | 2 |
| Dorsal | 40 | 36 | 76 |
| Lateral | 0 | 0 | 0 |
| Other | 9 | 7 | 16 |
| History of Spinal Surgery(Participants) | Adherus Dural Sealant (Test Group) | DuraSeal Exact (Control Group) | Total |
|---|---|---|---|
| Count of participants | 7 | 5 | 12 |
1 further baseline measures are reported on the registry.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Cerebrospinal Fluid Otorrhea