CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 269 enrolled
Drug / intervention
Prodigy, Prodigy MRI or Proclaim Elite IPGdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03082261
NCT03082261N/ACompleted

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

Abbott Medical Devices·interventional·Posted Mar 17, 2017·Updated Jul 8, 2021

In Brief

A clinical study evaluating Prodigy, Prodigy MRI or Proclaim Elite IPG for Chronic Pain and Intractable Pain. Completed, enrolled 269 participants across 22 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Finland, Germany, Italy, Spain, Switzerland, United States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMar 17, 2017
Enrollment StartMar 3, 2017
Primary CompletionJan 24, 2019
Study CompletionAug 26, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.3 years ago

Interventions

Prodigy, Prodigy MRI or Proclaim Elite IPGdevice

Subjects will be permanently implanted with either a Prodigy, Prodigy MRI or Proclaim Elite IPG