Seal-V Safety and Performance Study

Sealantis

Status and phase: Completed; Phase 1

Conditions: C.Surgical Procedure; Vascular (Peripheral)

Treatments: Device: Seal-V

Study type: Interventional

Funder types: Industry

Identifiers

NCT01625481

WP2-072-02

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Seal-V

Experimental group

Description:

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

Treatment:

Device: Seal-V