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

General Electric (GE)

Status and phase: Completed; Phase 4

Conditions: Echocardiography

Treatments: Drug: Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00730964

GE-191-003

Details and patient eligibility

About

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

Enrollment: 1,039 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

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

Trial design

1,039 participants in 1 patient group

Phase 4

Other group

Description:

Open Label

Treatment:

Drug: Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP)