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