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Progel Vascular Sealant

NCT01959503 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2017-04-10

Study results available
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Summary

This study is being conducted to evaluate the safety and effectiveness of the Progel Vascular Sealant for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.

Conditions

  • Aortic Valve Stenosis
  • Aneurysm of Ascending Aorta
  • Aortic Valve Disorder
  • Bicuspid Valve Disorder

Interventions

DEVICE

Progel Vascular Sealant

DEVICE

Gelfoam Plus

Sponsors & Collaborators

  • C. R. Bard

    lead INDUSTRY

Principal Investigators

  • Ali Khoynezhad, MD · Cedars-Sinai Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United States

Study Locations

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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 NCT01959503 on ClinicalTrials.gov