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

NCT03374735 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2017-12-15

No results posted yet for this study

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

  • Vascular Diseases

Interventions

DEVICE

SETALUM™ Sealant

SETALUM™ Sealant to be applied on the suture line

Sponsors & Collaborators

  • Gecko Biomedical

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-15
Primary Completion
2017-02-07
Completion
2017-10-03

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03374735 on ClinicalTrials.gov