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NCT03374735

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

Completed NA Last updated 15 December 2017
What this trial tests

NA trial testing SETALUM™ Sealant in Vascular Diseases in 22 participants. Completed in 3 October 2017.

Timeline
15 March 2016
Primary endpoint
7 February 2017
3 October 2017

Quick facts

Lead sponsorGecko Biomedical
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment22
Start date15 March 2016
Primary completion7 February 2017
Estimated completion3 October 2017

Drugs / interventions tested

Conditions studied

Sponsor

Gecko Biomedical

Who can join

18 and older, any sex, with Vascular Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Vascular Diseases

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03374735.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing