Seal-V Safety and Performance Study

NCT ID: NCT01625481

Last Updated: 2014-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-03-31

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.

Conditions

C.Surgical Procedure; Vascular (Peripheral)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Seal-V

A vascular sealant intended to achieve adjunctive hemostasis by mechanically sealing areas of potential leakage in surgical reconstruction of large blood vessels.

Group Type: EXPERIMENTAL

Seal-V

Intervention Type: DEVICE

Seal-V is applied adjunctively to cover the suture lines.

Interventions

Seal-V

Seal-V is applied adjunctively to cover the suture lines.

Intervention Type: DEVICE

Other Intervention Names

SEAlantis Vascular WP2(A)

Eligibility Criteria

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

• Major intraoperative complications that require resuscitation or deviation from the planned surgical procedure
• Local infection at the operating field

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sealantis Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rina Lev, PhD

Role: STUDY_DIRECTOR

Sealantis Ltd.

Locations

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 Litwinsky, , Israel

Countries

Israel

Other Identifiers

WP2-072-02

Identifier Type: -

Identifier Source: org_study_id