NCT03082261

Multi-center Prospective Study Determining the Sustainability of Pain Relief and Psychosocial and Functional Responses When Utilizing a Multiple Waveform Enabled Neurostimulator

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 269 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Chronic Pain
• Intractable Pain

Interventions

Type	Name	Description
DEVICE	Prodigy, Prodigy MRI or Proclaim Elite IPG	Subjects will be permanently implanted with either a Prodigy, Prodigy MRI or Proclaim Elite IPG

Timeline

• Start date: 2017-03-03
• Primary completion: 2019-01-24
• Completion: 2020-08-26
• First posted: 2017-03-17
• Last updated: 2021-07-08
• Results posted: 2021-06-02

Locations

22 sites across 7 countries: United States, Canada, Finland, Germany, Italy, Spain, Switzerland

Regulatory

• FDA-regulated device study