Trials / Completed
CompletedNCT03374735
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Gecko Biomedical · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SETALUM™ Sealant | SETALUM™ Sealant to be applied on the suture line |
Timeline
- Start date
- 2016-03-15
- Primary completion
- 2017-02-07
- Completion
- 2017-10-03
- First posted
- 2017-12-15
- Last updated
- 2017-12-15
Source: ClinicalTrials.gov record NCT03374735. Inclusion in this directory is not an endorsement.