Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02891070 | Efficacy and Safety of FS VH S/D 500 S-apr (Tisseel) as an Adjunct to Sutured Dural Repair in Cranial Surgery | PHASE3 | COMPLETED | 224 | — | — | Oct 11, 2016 | Aug 22, 2018 | Sep 10, 2019 | 25 | United States, Czechia +2 |
Participants who have no intra-operative CSF leak from dural repair after up to two applications during Valsalva maneuver (25 cm H2O for up to 5 - 10 seconds), or post-operative CSF leak within 30 (+3) days post-operatively. The Valsalva maneuver was performed by the anaesthesiologist to increase the intra-thoracic pressure (e.g., by increasing the positive end-expiratory pressure or by giving a large tidal volume and holding the inflating pressure) to approximately 25 cm H2O, constantly for up to 5 - 10 seconds to transiently elevate the intracranial pressure and test for any CSF leaks. The suture line was to be watertight after up to two product/control applications and Valsalva maneuvers.
| Arm | Type | Description |
|---|---|---|
| FS VH S/D 500 s-apr | EXPERIMENTAL | FS VH S/D 500 s-apr (Tisseel), single use treatment, intraoperative |
| DuraSeal Dural Sealant | ACTIVE_COMPARATOR | DuraSeal Dural Sealant, single use treatment, intraoperative |
| Name | Type | Description |
|---|---|---|
| FS VH S/D 500 s-apr | DRUG | - |
| DuraSeal Dural Sealant | DEVICE | - |
Inclusion Criteria: 1. Patients undergoing craniotomy/craniectomy for pathological processes in the PF or ST region 2. Patients must be willing and able to participate in the study and provide written IC before any protocol specific assessment is performed 3. Patients must be willing to receive per...