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 range18 Years – 75 Years
SexALL
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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
✕. 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.
What they're measuring
1
The proportion of treated subjects who are free from the following incidences:
✕. 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.