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

NCT03374735 | Completed DMC

• 1 other identifier: GB02-CL-1401
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Vascular Diseases

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

SETALUM™ Sealant

EXPERIMENTAL

SETALUM™ Sealant to be applied on the suture line

Device: SETALUM™ Sealant

Interventions

SETALUM™ Sealant DEVICE

SETALUM™ Sealant to be applied on the suture line

SETALUM™ Sealant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old;
• Surgical placement of an ePTFE patch for large carotid repair;
• Written informed consent given by the patient.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gecko Biomedical: lead

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 15, 2017
• Study Start: March 15, 2016
• Primary Completion: February 7, 2017
• Study Completion: October 3, 2017
• Last Updated: December 15, 2017

Record last verified: 2017-12