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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Subject has durotomy edges that can be re-approximated using the investigator's standard methods of dural repair.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The proportion of treated subjects who are free from the following incidences:
. 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.
. 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.