A Prospective Surveillance Trial to Evaluate the Safety of Optison in Clinical Practice.
OSSAR
A Post-marketing Surveillance Study of the Occurrence of Serious Adverse Reactions Among Patients Who Receive Optison in Routine Medical Practice
1 other identifier
interventional
1,039
1 country
1
Brief Summary
This prospective surveillance trial will gather safety information for Optison when it is used in routine practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 5, 2008
CompletedFirst Posted
Study publicly available on registry
August 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
June 12, 2012
CompletedJune 12, 2012
May 1, 2012
1.4 years
August 5, 2008
April 5, 2012
May 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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.
Within 24 hours post contrast administration
Secondary Outcomes (1)
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
Study Arms (1)
Phase 4
OTHEROpen Label
Interventions
The recommended dose of Optison is 0.5mL injected into a peripheral vein. This may be repeated for further contrast enhancement as needed. The injection rate should not exceed 1mL per second. Follow the Optison injection with a flush of 0.9% sodium chloride injection, USP or 5% dextrose in water injection, United States Pharmacopeia (USP) . The maximum total dose should not exceed 5.0mL in any 10 minutes period. The maximum total dose should not exceed 8.7mL in any one patient study.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Known hypersensitivity to perflutren, blood, blood products or albumin.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GE Healthcarelead
Study Sites (1)
GE Healthcare
Princeton, New Jersey, 08540, United States
MeSH Terms
Interventions
Results Point of Contact
- Title
- Rubin Sheng, MD
- Organization
- GE Healthcare
Study Officials
- STUDY DIRECTOR
Rubin Sheng, MD
GE Healthcare
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2008
First Posted
August 8, 2008
Study Start
May 1, 2008
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
June 12, 2012
Results First Posted
June 12, 2012
Record last verified: 2012-05