Seal-V Safety and Performance Study

Prospective, Single Arm, Open Label, Non-randomized Study to Evaluate The Safety and Performance of The Seal-V System

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 Overview

• Status: Completed
• Conditions: C.Surgical Procedure; Vascular (Peripheral)
• Intervention / Treatment: Device: Seal-V

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Department of Vascular Surgery, Bnai-Zion Medical Center
  • Haifa, Israel
    • Vascular Surgery Department, Rambam Health Care
  • Tel Hashomer, Israel, 52621
    • Department of Vascular Surgery, Chaim Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female of >18 years of age
• Signed Informed Consent
• Patients requiring vascular reconstruction surgeries using synthetic (such as PTFE, Dacron) or autologous (such as native veins) grafts, including the following:
• Peripheral bypass surgeries, such as arterio-arterial bypasses [including: axillo-(bi)femoral, ilio-(bi)femoral, femoro-femoral, ilio-popliteal, femoro-popliteal (including below knee), femoro-tibial vessel bypass]
• Arteriovenous (AV) dialysis access shunt in the upper or lower extremity
• Patients able and willing to complete all follow-up visits

Exclusion Criteria:

• Vascular surgery other than peripheral bypass surgeries and arteriovenous (AV) dialysis access shunt procedures as described above
• Reoperation at the same treatment site
• Known sensitivity to device materials, such as indigo carmine dye or alginate
• Pregnant or lactating women
• Systemic infection
• Participation in another clinical trial or treatment with any investigational agent in past 30 days
• Congenital coagulation disorders (e.g., thrombocytopenia [<100,000 platelet count], thromboasthenia, hemophilia, or von Willebrand disease)
• Severe congenital or acquired immunodeficiency (e.g., HIV infection or long term treatment with immunosuppressive drugs)
• Prior radiation therapy to the operating field

Intraoperative Exclusion Criteria:

• Major intraoperative complications that require resuscitation or deviation from the planned surgical procedure
• Intraoperative change in planned surgical procedure that results in the patient no longer meeting preoperative inclusion and/or exclusion criteria
• Local infection at the operating field

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Seal-V; A vascular sealant intended to achieve adjunctive hemostasis by mechanically sealing areas of potential leakage in surgical reconstruction of large blood vessels.	Device: Seal-V; Seal-V is applied adjunctively to cover the suture lines.; Other Names: SEAlantis Vascular WP2(A)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	Perioperative
Incidence of successful deployment of the Seal-V device		Perioperative

Collaborators and Investigators

• Sponsor: Sealantis Ltd.
• Investigators: Study Director: Rina Lev, PhD, Sealantis Ltd.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: June 19, 2012
• First Submitted That Met QC Criteria: June 20, 2012
• First Posted (Estimate): June 21, 2012

Study Record Updates

• Last Update Posted (Estimate): May 28, 2014
• Last Update Submitted That Met QC Criteria: May 26, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: WP2-072-02