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Hello All,

Have any of you had experience in getting the contrast package unlocked by the manufacturer for clinical off-label use outside of a IRB approved research study?

Do they require some sort of IRB for this or they do not care since it is approved for cardiac use?

Best wishes,

Tobias

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Replies to This Discussion

Hi,

Sorry for the delayed response. 

I think it depends on the manufacture. I believe you need to pay extra money to get software for most of the machines. But you may not, i.e., Philips iU22 comes with contrast software installed, you don't need to pay extra. I recommend you contact the company  (the ultrasound machine you are using). They will tell you exactly what they need from you. 

I do not think you need any IRB to get the contrast package. It is FDA approved.

For off-label use, you can do 2 ways: 1) if you are doing research study, or want to publish your data in the future, you need to go through your IRB 2) if you are using it for patients' care. No intent for research or publication, then you do not need IRB. 

Yuko

Hi,

We also recently unlocked the contrast mode for off-label abdominal use on a GE Logiq E9 without an IRB study.  There was a fee, unfortunately.

Good luck!

Rob Bour

University of Wisconsin Abdominal Imaging Fellow

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