Clinical trials are research studies that rely on human volunteers to answer specific medical questions related
to the treatment of disease. The results of clinical trials help determine the safest and most effective medical therapies, and shape the development of the next generation of medical treatments.
UBNS actively participates in four types of clinical trials, which represent a major component of our overall research program:
Investigational Device Exemptions (IDEs)
- Allows an experimental medical device to be used on patients in a controlled setting in order to collect data to support a Premarket Approval application to the Food and Drug Administration (FDA). An IDE may also be used to study the effectiveness and safety of new uses for legally marketed devices.
Humanitarian Device Exemptions (HDEs)
- Is intended to provide safety data to the FDA for the approval of a Humanitarian Use Device (HUD). HUDs are devices that diagnose or treat a disorder that affects fewer than 4,000 individuals in the United States per year. An HUD/HDE designation provides incentive for the development of devices for small populations since the research and development costs to the manufacturer may otherwise outweigh the market return. To gain FDA approval the HDE study must prove that the device does not pose an unreasonable risk of illness or injury, and that the probable benefit to health outweighs any possible risks.
Post-market Approval (PMA)
- Is a clinical trial sometimes requested by the FDA to further test the safety and benefit of a medical device after an IDE study is complete and the device has been approved. PMAs collect long-term data to study “real-world results.” In some cases, manufacturers sponsor PMAs to obtain physician input on possible device improvements.
- Is retrospective in nature, and involves the review of patient charts.
Currently, UBNS is enrolling patients in a multitude of clinical trials that treat a gamut of neurological disorders, including:
TIGER (RAPID MED)
SMART (Penumbra coil)
ICH (Intracerebral Hemorrhage)
For more information on clinical trials, contact Jennifer Gay, UBNS Research Study Coordinator, at (716) 929-9643 or firstname.lastname@example.org.