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The purpose of this study is to further assess the safety and performance of Seal-V as an adjunct to standard surgical procedure for achieving hemostasis in patients undergoing peripheral vascular reconstruction surgeries using synthetic grafts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seal-V | Experimental | A vascular sealant intended to achieve adjunctive hemostasis by mechanically sealing areas of potential leakage in surgical reconstruction of large blood vessels. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seal-V | Device | Seal-V is applied adjunctively to cover the suture lines. |
|
| Measure | Description | Time Frame |
|---|---|---|
| TTH, Time to Hemostasis | Duration from the point at which circulation is restored to the graft/artery until bleeding ceases at the treatment site | Perioperative; within 10 minutes after clamp release |
| Measure | Description | Time Frame |
|---|---|---|
| Successful cessation of bleeding at a treatment site | Perioperative; within 10 minutes after clamp release | |
| Intraoperative blood loss | Measured by weighing the surgical swabs used only in the application area and used from the time Seal-V was applied until hemostasis |
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Inclusion Criteria:
Exclusion Criteria:
Intraoperative Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rina Lev, PhD | Sealantis Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Vascular Surgery, Bnai-Zion Medical Center | Haifa | Israel | ||||
| Vascular Surgery Department, Rambam Health Care |
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| Perioperative |
| Incidence of successful deployment of the Seal-V device | Perioperative |
| Haifa |
| Israel |
| Department of Vascular Surgery, Chaim Sheba Medical Center | Tel Litwinsky | 52621 | Israel |