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X-Seal EU Post-Market Clinical Follow-Up Protocol

NCT02406612 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2018-10-29

Study results available
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Summary

The study is designed to prospectively collect data on and confirm the safety and effectiveness of the X-Seal 6F Vascular Closure System in reducing time to hemostasis and time to ambulation for patients who have undergone diagnostic or interventional catheterization procedures using up to 6F sheaths when compared with standard compression techniques using data from literature surveys.

Conditions

  • Femoral Arteriotomy Closure

Interventions

DEVICE

X-Seal 6F Vascular Closure Device

Sponsors & Collaborators

  • Essential Medical, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-02-29
Completion
2016-06-30

Countries

  • Germany

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 NCT02406612 on ClinicalTrials.gov