Seal-V Safety and Performance Study

Phase 1

Completed

• Conditions: C.Surgical Procedure; Vascular (Peripheral)
• Interventions: Device: Seal-V

• Registration Number: NCT01625481
• Lead Sponsor: Sealantis Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-19
• Study First Submitted QC: 2012-06-20
• Study First Posted: 2012-06-21
• Study Start: 2012-07
• Primary Completion: 2013-12
• Study Completion: 2014-03
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-26
• Last Update Posted: 2014-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Seal-V	Seal-V	A vascular sealant intended to achieve adjunctive hemostasis by mechanically sealing areas of potential leakage in surgical reconstruction of large blood vessels.

Primary Outcome Measures

Name	Time	Method
TTH, Time to Hemostasis	Perioperative; within 10 minutes after clamp release	Duration from the point at which circulation is restored to the graft/artery until bleeding ceases at the treatment site

Secondary Outcome Measures

Name	Time	Method
Intraoperative blood loss	Perioperative	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	Perioperative
Successful cessation of bleeding at a treatment site	Perioperative; within 10 minutes after clamp release

Trial Locations

Locations (3)

Department of Vascular Surgery, Chaim Sheba Medical Center; 🇮🇱 Tel Hashomer, Israel

Vascular Surgery Department, Rambam Health Care; 🇮🇱 Haifa, Israel

Department of Vascular Surgery, Bnai-Zion Medical Center; 🇮🇱 Haifa, Israel