Seal-V Safety and Performance Study
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective, Single Arm, Open Label, Non-randomized Study to Evaluate The Safety and Performance of The Seal-V System|
- TTH, Time to Hemostasis [ Time Frame: Perioperative; within 10 minutes after clamp release ] [ Designated as safety issue: Yes ]Duration from the point at which circulation is restored to the graft/artery until bleeding ceases at the treatment site
- Successful cessation of bleeding at a treatment site [ Time Frame: Perioperative; within 10 minutes after clamp release ] [ Designated as safety issue: Yes ]
- Intraoperative blood loss [ Time Frame: Perioperative ] [ Designated as safety issue: Yes ]Measured by weighing the surgical swabs used only in the application area and used from the time Seal-V was applied until hemostasis
- Incidence of successful deployment of the Seal-V device [ Time Frame: Perioperative ] [ Designated as safety issue: No ]
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
A vascular sealant intended to achieve adjunctive hemostasis by mechanically sealing areas of potential leakage in surgical reconstruction of large blood vessels.
Seal-V is applied adjunctively to cover the suture lines.
Other Name: SEAlantis Vascular WP2(A)
|Department of Vascular Surgery, Bnai-Zion Medical Center|
|Vascular Surgery Department, Rambam Health Care|
|Department of Vascular Surgery, Chaim Sheba Medical Center|
|Tel Hashomer, Israel, 52621|
|Study Director:||Rina Lev, PhD||Sealantis Ltd.|