Adherus™ Dural Sealant in Spinal Procedures
Part of paid clinical trials in Duarte, California.
- Sponsor
- Stryker Craniomaxillofacial
- Study ID
- NCT04498026
- Status
- Enrolling By Invitation
Conditions
- Spinal Duraplasty
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Adherus Dural Sealant System — DEVICEAdherus Dural Sealant, In situ polymerizing sealant
- DuraSeal Exact Dural Sealant System — DEVICEDuraSeal Exact (P080013b)
Study Details
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.
Key Dates
- Start date
- Nov 19, 2020
- Status verified
- Feb 2025
- Primary completion
- Dec 31, 2025
- Completion
- Dec 31, 2025
Study Design
- Enrollment
- 114 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Adherus Dural Sealant SystemDevice: Adherus Dural Sealant, In situ polymerizing sealant
- Active Comparator: DuraSeal Exact Dural Sealant SystemDevice: DuraSeal Exact (P080013b)
Primary Outcome Measure
The proportion of treated subjects who are free from the following incidences: [ Time Frame: 90 Days ]
Locations (14)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010 | - |
| University of California Davis Health | Sacramento | California | 95817 | - |
| Stanford University | Stanford | California | 94305 | - |
| Mayo Clinic (FL) | Jacksonville | Florida | 32224 | - |
| Rush University Medical Center | Chicago | Illinois | 60612 | - |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | - |
| Mayo Clinic | Rochester | Minnesota | 55902 | - |
| Columbia University Irving Medical Center | New York | New York | 10032 | - |
| Carolina Neurosurgery & Spine Associates | Charlotte | North Carolina | 28204 | - |
| Duke University | Durham | North Carolina | 27705 | - |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | - |
| Houston Methodist Research Institute | Houston | Texas | 77030 | - |
| University of Texas M.D. Anderson Cancer Center | Houston | Texas | 77030 | - |
| Carilion Clinic | Roanoke | Virginia | 24014 | - |