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

NCT ID: NCT03374735

Last Updated: 2017-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-15

Study Completion Date

2017-10-03

Brief Summary

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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.

Detailed Description

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Conditions

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Vascular Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SETALUM™ Sealant

SETALUM™ Sealant to be applied on the suture line

Group Type EXPERIMENTAL

SETALUM™ Sealant

Intervention Type DEVICE

SETALUM™ Sealant to be applied on the suture line

Interventions

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SETALUM™ Sealant

SETALUM™ Sealant to be applied on the suture line

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gecko Biomedical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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GB02-CL-1401

Identifier Type: -

Identifier Source: org_study_id