First In-human Use of SETALUM™ Sealant: The BlueSeal Clinical Study

Gecko Biomedical22 enrolled

Overview

This is a prospective, multicenter, single-arm trial to evaluate the safety and performance of SETALUM™ Sealant in sealing suture lines at the anastomosis between native vessels and synthetic ePTFE vascular patch used during open vascular surgery.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Vascular Diseases

Interventions

SETALUM™ SealantDEVICE

SETALUM™ Sealant to be applied on the suture line

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ≥18 years old; * Surgical placement of an ePTFE patch for large carotid repair; * Written informed consent given by the patient. Exclusion Criteria: * Known or suspected allergy or sensitivity to any test materials or reagents; * Concomitant intake of immunosuppressive medications; * Prior radiation therapy to the operating field; * Previous surgical procedure performed on the same operating field; * Current or recent (\<3months) participation in another investigational study; * Refusal to receive blood products; * Pregnant or breast-feeding women

Outcomes

Primary Outcomes

Elapsed time from clamp release to hemostasis at the suture line

The hemostasis is observed by the operating surgeon and timed by an operative room nurse. Anastomotic hemostasis is defined as an anastomosis not requiring any additional intervention to control bleeding.

Time frame: During surgical procedure

All adverse events occurring from the surgical procedure to Week 12

Each Adverse Event was described by the seriouness and the nature of its relationship to the SETALUM™ Sealant or to the surgical procedure. The Data Monitoring Committee reviewed all occurred adverse events and provided a conclusion on the SETALUM™ Sealant safety profile.

Time frame: Week 12

Data from ClinicalTrials.gov

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