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

Vascular Diseases Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03374735
• Other study ID #: GB02-CL-1401
• Status: Completed
• Phase: N/A
• First received: December 5, 2017
• Last updated: December 11, 2017
• Start date: March 15, 2016
• Est. completion date: October 3, 2017

Study information

• Verified date: December 2017
• Source: Gecko Biomedical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 3, 2017
• Est. primary completion date: February 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Vascular Diseases

Intervention

Device:
• SETALUM™ Sealant
SETALUM™ Sealant to be applied on the suture line

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gecko Biomedical

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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