The objective of this proposal is to develop a prototype device capable of cooling extremities to a level sufficient for prevention of chemotherapy-induced peripheral neuropathy (CIPN). Such a product will enable healthcare providers to make available a solution to prevent the physical pain and reduction in quality of life resulting from CIPN. The following Aims will be completed: (1) design, build, and validate prototypes, and (2) conduct usability and tolerability studies in a small patient cohort undergoing chemotherapy. The end of project deliverable is a validated Medacool™ prototype device with adjustable temperature within a tolerable therapeutic range with the ability to cool to therapeutic levels for 8+ hours. Through user feedback acquired in partnership with Eminence Clinical Research, Inc., the device will demonstrate ease of use in performing all critical tasks with no critical faults. The study will further provide initial indications of tolerability as well as aid in the design of a next generation prototype amenable to in-clinic, in-transit, and in-home portability for a planned Phase II pivotal efficacy and safety study in 250 patients.
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