EchocardiographyPhase 4OSSARNCT00730964
A Prospective Surveillance Trial to Evaluate the Safety of Optison in Clinical Practice.
A Phase 4 study testing Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP) in people with Echocardiography, run by GE Healthcare at 1 site in United States.
Trial summary
This prospective surveillance trial will gather safety information for Optison when it is used in routine practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Echocardiography
- What is being tested?
- Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,039 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Oct 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Known hypersensitivity to perflutren, blood, blood products or albumin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Post-marketing Surveillance Study of the Occurrence of Serious Adverse Reactions Among Patients Who Receive Optison in Routine Medical Practice
This prospective surveillance trial will gather safety information for Optison when it is used in routine practice.
- Conditions
- Echocardiography
- Being tested
- Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP)
- Keywords
- Surveillance, Optison, Perflutren, Echocardiography, Subjects receive Optison during enhanced echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP)Drug
Also called Optison
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.
| Study group | Role | What they receive |
|---|---|---|
| Phase 4 | Other | Open Label Receives: Drug: Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: Within 24 hours post contrast administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startMay 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for EchocardiographyStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,039 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rubin Sheng, MD, Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730964
- Sponsor's protocol ID
- GE-191-003
- Acronym
- OSSAR
- Status last verified
- May 2012
- First submitted
- 5 Aug 2008
- Last updated
- 12 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-marketing Surveillance Study of the Occurrence of Serious Adverse Reactions Among Patients Who Receive Optison in Routine Medical Practice
- ClinicalTrials.gov ID
- NCT00730964
- Acronym / sponsor ID
- OSSAR / GE-191-003
- Conditions
- Echocardiography
- Keywords
- Surveillance, Optison, Perflutren, Echocardiography, Subjects receive Optison during enhanced echocardiography
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,039 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 8 Aug 2008 (estimated)
- Results
- Posted 12 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective surveillance trial will gather safety information for Optison when it is used in routine practice.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase 4 | Other | Drug: Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP)Open Label |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Known hypersensitivity to perflutren, blood, blood products or albumin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP)Also: OptisonThe 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. | Drug | Phase 4 |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rubin Sheng, MD study director
GE Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP) in people with Echocardiography, run by GE Healthcare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2012.