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A Post-marketing Surveillance Study of the Occurrence of Serious Adverse Reactions Among Patients Who Receive Optison in Routine Medical Practice (OSSAR)
This prospective surveillance trial will gather safety information for Optison when it is used in routine practice.
Details
| Lead sponsor | GE Healthcare |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 1039 |
| Start date | 2008-05 |
| Completion | 2009-10 |
Conditions
- Echocardiography
Interventions
- Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP)
Primary outcomes
- 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.
Countries
United States