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

Gecko Biomedical

Status: Completed

Conditions: Vascular Diseases

Treatments: Device: SETALUM™ Sealant

Study type: Interventional

Funder types: Industry

Identifiers

NCT03374735

GB02-CL-1401

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

22 participants in 1 patient group

SETALUM™ Sealant

Experimental group

Description:

SETALUM™ Sealant to be applied on the suture line

Treatment:

Device: SETALUM™ Sealant