Status:
COMPLETED
First In-human Use of SETALUM™ Sealant: The BlueSeal Clinical Study
Lead Sponsor:
Gecko Biomedical
Conditions:
Vascular Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
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 va...
Eligibility Criteria
Inclusion
- ≥18 years old;
- Surgical placement of an ePTFE patch for large carotid repair;
- Written informed consent given by the patient.
Exclusion
- 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
Key Trial Info
Start Date :
March 15 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2017
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03374735
Start Date
March 15 2016
End Date
October 3 2017
Last Update
December 15 2017
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