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Clinical Trial Summary

The TRIUMPH study is a post-market, international, multicenter, interventional, prospective, single-arm study intended to evaluate the sustainability of pain control and psychosocial and functional responses utilizing a multiple-waveform enabled neurostimulator in subjects with chronic, intractable pain of the trunk and/or limbs.


Clinical Trial Description

TRIUMPH study will utilize the multiprogram trial stimulator or invisible trial system with BurstDR for the trial evaluation period and the Prodigy or Proclaim Elite family of neurostimulators with tonic or BurstDR waveform at permanent implant and follow-up for pain control and improvement of psychosocial function. The follow-up visits will be scheduled at 3, 6, 12, 18, and 24 months post permanent implant ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03082261
Study type Interventional
Source Abbott Medical Devices
Contact
Status Completed
Phase N/A
Start date March 3, 2017
Completion date August 26, 2020

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