I think it is very complicated to get IRB approval for a clinical trial where the outcome is unknown. The IRB wants to make sure that a device will offer no potential harm to any subjects, and this is a case where the outcome is unknown and the researcher can’t be sure that no harm will be done. Thus this is not a likely area for students to study. Such an IRB would more likely be obtained by a hospital or device company that has more structures in place to support such research. Also this type of research takes a very long time to conduct.