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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00730964
First received: August 5, 2008
Last updated: May 9, 2012
Last verified: May 2012
Results First Received: April 5, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Echocardiography
Intervention: Drug: Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Arm 1 - Optison Open Label with 1039 subjects that received Optison to evaluate the safety of the product

Participant Flow:   Overall Study
    Arm 1 - Optison  
STARTED     1039  
COMPLETED     1039  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Arm 1 - Optison Open Label with 1039 subjects that received Optison to evaluate the safety of the product

Baseline Measures
    Arm 1 - Optison  
Number of Participants  
[units: participants]
  1039  
Age  
[units: years]
Mean ± Standard Deviation
  59.9  ± 12.99  
Age, Customized  
[units: participants]
 
<=65 years     671  
Between 65 and 75 years     227  
>=75 years     141  
Gender  
[units: participants]
 
Female     391  
Male     648  
Region of Enrollment  
[units: participants]
 
United States     1039  



  Outcome Measures
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1.  Primary:   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.   [ Time Frame: Within 24 hours post contrast administration ]

2.  Secondary:   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.   [ Time Frame: Within 24 hours post contrast administration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Rubin Sheng, MD
Organization: GE Healthcare
phone: 1-609-514-6899
e-mail: Rubin.Sheng@ge.com


No publications provided


Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT00730964     History of Changes
Other Study ID Numbers: GE-191-003
Study First Received: August 5, 2008
Results First Received: April 5, 2012
Last Updated: May 9, 2012
Health Authority: United States: Food and Drug Administration