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The Mamma HiToP Study
The HiToP ® 191 PNP an certified device licensed for the treatment of neuropathia. The home-based treatment is to be performed only in accordance with the approved Investigational Plan (CIP) on subjects who have signed an informed consent form. Device use is limited to the approved study investigators. The study is multicenter, randomized, double-blind, and placebo-controlled. Primary Objective: Comparison of the change of paresthesias from baseline until end of therapy between the two patient groups, assessed by questionnaires Secondary Objectives: Further symptoms of neuropathy as well as on health-related quality of life.
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