Skip to main content
OpenTrials
Completed

NCT Number: NCT00730964

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Echocardiography

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GE Healthcare

Princeton, New Jersey, 08540, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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.

Other names: Optison

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.

    Time frame: 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 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Registry information

Official study title

A Post-marketing Surveillance Study of the Occurrence of Serious Adverse Reactions Among Patients Who Receive Optison in Routine Medical Practice

Acronym: OSSAR

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 8, 2008
Registry last updated
Jun 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.