Clinical Trial TitleA 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
National Clinical Trial Number:NCT04498026
Clinical Trial Protocol 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 (P080013b) as an active control. The trial is designed to demonstrate non-inferiority of Adherus Dural Sealant to DuraSeal Exact.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are ≥ 18 and ≤ 75 years of age.
- Are scheduled for an elective spinal procedure that will require a planned durotomy.
- Require a procedure involving a Class I/clean wound (uninfected surgical wound in which no inflammation is encountered).
Intra-Operative Inclusion Criteria:
- Have durotomy edges that can be re-approximated using the investigator’s standard methods of dural repair.
You will be excluded from the study if any of the following criteria apply to you:
- Have undergone a previous spinal procedure in the same anatomical location.
- Have clinically significant hydrocephalus or clinical evidence of altered CSF dynamics.
- Have a known allergy to FD&C Blue #1 and/or FD&C Yellow #5 or any of the constituents of the dural sealants.
- Are pregnant, breast-feeding, or intends to become pregnant during the course of the study.
- Are participating in a clinical trial of another investigational drug or device and has not completed the required follow-up period.
Intra-Operative Exclusion Criteria:
- Have a dural defect that cannot be closed with suture and/or duraplasty material.
- Have 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.
- Have undergone laminoplasty decompression.
- Have undergone a syringomyelia procedure where the shunt is not placed in the subarachnoid position.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.