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

Prospective, Multicenter, Non-controlled Study, Evaluating Safety and Performance of SETALUM™ Sealant as an add-on to Suture in Vascular Reconstruction in Patients Undergoing Carotid Enlargement Procedure Using an ePTFE Patch.

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 Overview

• Status: Completed
• Conditions: Vascular Diseases
• Intervention / Treatment: Device: SETALUM™ Sealant

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SETALUM™ Sealant; SETALUM™ Sealant to be applied on the suture line	Device: SETALUM™ Sealant; SETALUM™ Sealant to be applied on the suture line

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Week 12

Collaborators and Investigators

• Sponsor: Gecko Biomedical

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2016
• Primary Completion (Actual): February 7, 2017
• Study Completion (Actual): October 3, 2017

Study Registration Dates

• First Submitted: December 5, 2017
• First Submitted That Met QC Criteria: December 11, 2017
• First Posted (Actual): December 15, 2017

Study Record Updates

• Last Update Posted (Actual): December 15, 2017
• Last Update Submitted That Met QC Criteria: December 11, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: GB02-CL-1401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No