Status:

COMPLETED

A Prospective Surveillance Trial to Evaluate the Safety of Optison in Clinical Practice.

Lead Sponsor:

GE Healthcare

Conditions:

Echocardiography

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

This prospective surveillance trial will gather safety information for Optison when it is used in routine practice.

Eligibility Criteria

Inclusion

  • The subject is over 18 years old.
  • The subject has been scheduled for an Optison-enhanced echocardiography exam.
  • The subject has provided signed and dated informed consent.

Exclusion

  • Known hypersensitivity to perflutren, blood, blood products or albumin.

Key Trial Info

Start Date :

May 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2009

Estimated Enrollment :

1039 Patients enrolled

Trial Details

Trial ID

NCT00730964

Start Date

May 1 2008

End Date

October 1 2009

Last Update

June 12 2012

Active Locations (1)

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1

GE Healthcare

Princeton, New Jersey, United States, 08540