Ignite Creation Date:
2025-12-24 @ 12:02 PM
Ignite Modification Date:
2025-12-27 @ 10:00 PM
Study NCT ID:
NCT03082261
Status:
COMPLETED
Last Update Posted:
2021-07-08
First Post:
2017-03-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multi-center Prospective Study Determining the Sustainability of Pain Relief and Psychosocial and Functional Responses When Utilizing a Multiple Waveform Enabled Neurostimulator
Sponsor:
Abbott Medical Devices
Organization:
Study Overview
Official Title:
Multi-center Prospective Study Determining the Sustainability of Pain Relief and Psychosocial and Functional Responses When Utilizing a Multiple Waveform Enabled Neurostimulator
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRIUMPH
Brief 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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: