Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To collect post-approval data comparing the safety and effectiveness of CraniSeal Dural Sealant to DuraSeal Dural Sealant. The study has been powered specifically to determine whether the CraniSeal device when used as an adjunct to sutured dural closure following elective cranial surgery is no worse than (i.e., non-inferior) to the DuraSeal device with respect to proportion of subjects free from post-operative cerebrospinal fluid (CSF) leaks. Additional safety outcomes (i.e., surgical site infections and adverse events/device-related adverse events) will also be captured and compared.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CraniSeal | Experimental | CraniSeal |
|
| DuraSeal | Active Comparator | DuraSeal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CraniSeal | Device | CraniSeal is a PEG Dural Sealant |
| |
| DuraSeal |
| Measure | Description | Time Frame |
|---|---|---|
| Absence of CSF Leaks | absence of CSF leaks on study | 90 days |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| TEAEs and TESAEs | treatment emergent events on study | 90 days |
General Inclusion Criteria:
General Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| M Pace | Contact | 6172335873 | mike.pace@pramandllc.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keck Medical Center at USC | Completed | Los Angeles | California | 90033 | United States | |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D065634 | Cerebrospinal Fluid Leak |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
Not provided
Not provided
Randomized 1:1 CraniSeal vs Comparator
Not provided
Not provided
Participant will be blinded to dural sealant until they have completed 90 day study.
| Device |
DuraSeal is a PEG Dural Sealant |
|
| Mayo Clinic |
| Recruiting |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| Tampa General Hospital | Recruiting | Tampa | Florida | 33606 | United States |
| Augusta University | Recruiting | Augusta | Georgia | 30912 | United States |
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
|
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
| Jacobs Institute | Recruiting | Buffalo | New York | 14203 | United States |
|
| Prisma Health | Recruiting | Greenville | South Carolina | 29605 | United States |
|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |