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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03374735

Enrollment

Registered

2017-12-15

Start date

2016-03-15

Completion date

2017-10-03

Last updated

2017-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Diseases

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.

Interventions

DEVICESETALUM™ Sealant

SETALUM™ Sealant to be applied on the suture line

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Elapsed time from clamp release to hemostasis at the suture line	During surgical procedure	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.
All adverse events occurring from the surgical procedure to Week 12	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026