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

Phase 4

Completed

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

• Registration Number: NCT00730964
• Lead Sponsor: GE Healthcare

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-08-05
• Study First Submitted QC: 2008-08-07
• Study First Posted: 2008-08-08
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Results First Submitted: 2012-04-05
• Status Verified: 2012-05
• Results First Submitted QC: 2012-05-09
• Last Update Submitted: 2012-05-09
• Results First Posted: 2012-06-12
• Last Update Posted: 2012-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1039

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase 4	Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP)	Open Label

Primary Outcome Measures

Name	Time	Method
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.	Within 24 hours post contrast administration	A Serious Adverse Reaction or (SAR) is considered causally related to the Optison product administered by the investigator. This reaction, should it occur, will be counted as a serious adverse reaction.

Secondary Outcome Measures

Name	Time	Method
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.	Within 24 hours post contrast administration	The frequency of any serious adverse event (SAE) whether it is related to the Optison product or not, after the administration of the Optison product during contrast enhanced echocardiography.

Trial Locations

Locations (1)

GE Healthcare; 🇺🇸 Princeton, New Jersey, United States