investigational device investigational device
A medical tool, instrument, or test that has not yet been approved for the reason being studied in the research.
Example of investigational device in a sentence
An investigational device can be studied to find out how safe it is and how well it works.
More Info
In healthcare, investigational devices can include things like new thermometers, new genetic test, tests to diagnose an illness, or even computer programs.
Some investigational devices that are used inside the body, like insulin pumps, pacemakers, and deep brain stem stimulators.
There are also investigational devices that are used outside the body, like hearing aids, genetic tests, insulin readers, and “smartwatch” wearables.
Researchers get approval before using an investigational device in a research study that enrolls people.
Other info to think about when joining a study
You might see the word “investigational device” in a research consent form.
If you have an investigational device inserted into your body as part of a research study, it is important to understand the risks and benefits, as well as what will happen to the device when the study is over.
If the research involves randomization, you can ask to find out more about what each study group will receive.
You can also clarify if the investigational device will be removed from you and returned back to the researchers when your time in the study is over.
If the device will not be removed, you can find out more about who to contact with questions about maintaining the device or how the device could affect your future medical care.
Even for investigational devices that are outside the body, you could still ask if you will get to keep it. For example, if you will be able to keep using an insulin reader from a study, or will have to return it.
