Seal-V Safety and Performance Study

Phase 1

Completed

• Conditions: C.Surgical Procedure; Vascular (Peripheral)

• 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

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
Incidence of successful deployment of the Seal-V device	Perioperative
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
Successful cessation of bleeding at a treatment site	Perioperative; within 10 minutes after clamp release

Trial Locations

Locations (3)

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

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

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