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Clinical Trial Summary

To obtain preliminary estimates of the safety and efficacy of the ANS Eon™ Implantable Pulse Generator with ANS leads in the treatment of subjects with diabetic polyneuropathy.


Clinical Trial Description

There is a medication arm and a stimulation arm. Patients will randomized to one or the other. If patients are randomized to the medication arm, after 6 months they have the option of going into the stimulation arm. There is a 3 week trial which includes a crossover period from "no stimulation" to subthreshold stimulation. The 3rd week patients will receive "optimal" stimulation. If they qualify, they will be implanted with the permanent device. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01536236
Study type Interventional
Source Abbott Medical Devices
Contact
Status Withdrawn
Phase N/A
Start date October 2011
Completion date October 2014

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