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

Information source: GE Healthcare
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Echocardiography

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

Phase: Phase 4

Status: Completed

Sponsored by: GE Healthcare

Official(s) and/or principal investigator(s):
Rubin Sheng, MD, Study Director, Affiliation: GE Healthcare


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

Clinical Details

Official title: A Post-marketing Surveillance Study of the Occurrence of Serious Adverse Reactions Among Patients Who Receive Optison in Routine Medical Practice

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Primary outcome: The Frequency of Serious Adverse Reactions (SAR)'s Among Subjects Who Receive Optison (Causally Related to the Product)During Contrast Enhanced Echocardiography in Routine Clinical Practice.

Secondary outcome: The Frequency of Overall Serious Adverse Events (SAE's) Among Subjects Who Receive Optison (Whether Related to the Product or Not) During Contrast Enhanced Echocardiography in Routine Clinical Practice.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

GE Healthcare, Princeton, New Jersey 08540, United States
Additional Information

Starting date: May 2008
Last updated: May 9, 2012

Page last updated: August 23, 2015

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