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

PHASE4CompletedINTERVENTIONAL
Enrollment

1,039

Participants

Timeline

Start Date

May 31, 2008

Primary Completion Date

October 31, 2009

Study Completion Date

October 31, 2009

Conditions
Echocardiography
Interventions
DRUG

Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP)

"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."

Trial Locations (1)

08540

GE Healthcare, Princeton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GE Healthcare

INDUSTRY

NCT00730964 - A Prospective Surveillance Trial to Evaluate the Safety of Optison in Clinical Practice. | Biotech Hunter | Biotech Hunter