Adherus Dural Sealant for Spinal Duraplasty
Recruiting in Palo Alto (17 mi)
+15 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Stryker Craniomaxillofacial
No Placebo Group
Trial Summary
What is the purpose of this trial?
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.
Research Team
Eligibility Criteria
This trial is for adults aged 18 to 75 who need elective spinal surgery involving a clean, uninfected wound. Candidates must have re-approximable durotomy edges and be able to attend follow-up visits. Exclusions include altered CSF dynamics, previous leaks or surgeries in the same spot, non-MRI compatible implants, severe health conditions like cancer with less than six months survival expectancy, recent chemotherapy or chronic steroid use without proper wash-out period, certain medication usage without pre-surgical pause, compromised immune systems or infections near the surgical site.Inclusion Criteria
I am scheduled for a spine surgery that includes opening the dura mater.
I need a procedure for a clean, uninfected wound.
My surgery involves repairing the outer layer of my brain or spinal cord.
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Exclusion Criteria
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.
I am having surgery for Chiari malformation.
Subject is pregnant, breast-feeding, or intends to become pregnant during the course of the study.
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Treatment Details
Interventions
- Adherus Dural Sealant System (Dural Sealant)
- DuraSeal Exact Dural Sealant System (Dural Sealant)
Trial OverviewThe study tests Adherus AutoSpray and Adherus AutoSpray ET Dural Sealant against FDA-approved DuraSeal Exact Spinal Sealant in spinal surgeries. The goal is to compare their effectiveness when used during procedures that require sealing of the dura mater (the tough outer membrane covering the brain and spinal cord) after it has been cut open.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Adherus Dural Sealant SystemExperimental Treatment1 Intervention
Device: Adherus Dural Sealant, In situ polymerizing sealant
Group II: DuraSeal Exact Dural Sealant SystemActive Control1 Intervention
Device: DuraSeal Exact (P080013b)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Saint AlphonsusBoise, ID
Rush University Medical CenterChicago, IL
Columbia University Irving Medical CenterNew York, NY
Houston Methodist Research InstituteHouston, TX
More Trial Locations
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Who Is Running the Clinical Trial?
Stryker Craniomaxillofacial
Lead Sponsor
Trials
2
Patients Recruited
220+
Fortrea
Collaborator
Trials
8
Patients Recruited
2,500+
Laboratory Corporation of America
Industry Sponsor
Trials
32
Patients Recruited
18,800+
Fortrea
Industry Sponsor
Trials
22
Patients Recruited
5,800+
Covance
Industry Sponsor
Trials
124
Patients Recruited
13,300+