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OpenTrials
Completed

NCT Number: NCT03374735

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

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.

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Key information

Conditions

Vascular Diseases Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SETALUM™ Sealant

Device

SETALUM™ Sealant to be applied on the suture line

Primary outcomes

  1. Elapsed time from clamp release to hemostasis at the suture line

    Time frame: 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.

  2. All adverse events occurring from the surgical procedure to Week 12

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Gecko Biomedical

Industry

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 15, 2017
Registry last updated
Dec 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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