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This is a multicentre, prospective, open-label, single-arm, observational, post-market clinical follow-up registry study designed to observe the safety and performance of the Immiseal™ Dural Sealant System when used as an adjunct to standard methods of dural repair to provide watertight closure during neurosurgical procedures. Eligible adult subjects requiring dural repair after neurosurgical procedures or traumatic injury, for whom the investigator has made the clinical decision to use the device, will be enrolled and followed for approximately 100 ± 10 days after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients Receiving Immiseal™ Dural Sealant System | Adult patients requiring dural repair following neurosurgical procedures or traumatic injury, for whom the investigator has made the clinical decision to use the Immiseal™ Dural Sealant System as an adjunct to standard methods of dural repair. Subjects will be followed for safety and device performance outcomes through approximately 100 ± 10 days post-operation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of Central Nervous System (CNS) Infection | Percentage of subjects with central nervous system infection up to 30 days post-operation, including bacterial meningitis, aseptic meningitis, and/or surgical site infection. | Up to 30 days post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebrospinal Fluid (CSF) Leak Rate | Percentage of subjects with cerebrospinal fluid leak after primary dural repair using the Immiseal™ Dural Sealant System, used to assess effective watertight dural closure. | Up to 100 ± 10 days post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| Meningitis Rate and Surgical Site Infection Rate Over the Study Period | Meningitis rate and surgical site infection rate will be observed over the course of the study. The analysis will be performed using Kaplan-Meier survival analysis over the whole follow-up period. | Up to 100 ± 10 days post-operation |
Inclusion Criteria:
Exclusion Criteria:
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Adult patients aged 18 to 75 years who require dural repair following neurosurgical procedures or traumatic injury and for whom the investigator has made the clinical decision to use the Immisealâ„¢ Dural Sealant System as an adjunct to standard methods of dural repair. Eligible patients may have dural defects associated with craniocerebral trauma, brain tumour, cerebrovascular disease, congenital disease of the nervous system, posterior fossa surgery, spinal canal disease, or other neurosurgical procedures or accidents, and may present with or be at risk of cerebrospinal fluid leakage requiring auxiliary dural repair.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuchuan Zhang | Contact | +86 20 32296118 | zhangyuchuan@medprin.com | |
| Xiaoting Liao | Contact | +86 15602300416 | liaoxiaoting@medprin.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riga East Clinical University Hospital | Recruiting | Riga | Latvia |
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| ID | Term |
|---|---|
| D065634 | Cerebrospinal Fluid Leak |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |