Back to resultsFirst In-human Use of SETALUM™ Sealant: The BlueSeal Clinical Study
Primary Purpose
Vascular Diseases
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SETALUM™ Sealant
Sponsored by
About this trial
This is an interventional treatment trial for Vascular Diseases
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SETALUM™ Sealant
Arm Description
SETALUM™ Sealant to be applied on the suture line
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03374735
Brief Title
First In-human Use of SETALUM™ Sealant: The BlueSeal Clinical Study
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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
March 15, 2016 (Actual)
Primary Completion Date
February 7, 2017 (Actual)
Study Completion Date
October 3, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gecko Biomedical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SETALUM™ Sealant
Arm Type
Experimental
Arm Description
SETALUM™ Sealant to be applied on the suture line
Intervention Type
Device
Intervention Name(s)
SETALUM™ Sealant
Intervention Description
SETALUM™ Sealant to be applied on the suture line
Primary Outcome Measure Information:
Title
Elapsed time from clamp release to hemostasis at the suture line
Description
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.
Time Frame
During surgical procedure
Title
All adverse events occurring from the surgical procedure to Week 12
Description
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.
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
First In-human Use of SETALUM™ Sealant: The BlueSeal Clinical Study
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