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The Safety and Efficacy of an Extravascular, Water-Soluble Sealant for Venous Access-Site Closure

NCT02438475 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2020-11-18

Study results available
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Summary

Evaluate the safety of the MynxGrip™ extravascular sealant for common femoral vein closure following both diagnostic and interventional procedures as assessed by clinical and imaging criteria.

Conditions

  • Cardiac Diagnostic Procedure
  • Cardiac Interventional Procedure
  • Femoral Access Site Closure

Interventions

DEVICE

Mynx Vascular Closure System

MynxGrip is being used to seal femoral vein access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath.

OTHER

Manual Compression

manual pressure applied to your groin for approximately 5-10 minutes

Sponsors & Collaborators

  • Cardinal Health

    collaborator INDUSTRY

  • Medstar Health Research Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2017-08-31
Completion
2017-08-31
FDA Device
Yes

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 NCT02438475 on ClinicalTrials.gov