Trials / Completed
CompletedNCT03908476
PROLONG Prospective, Multi-center, Open-label, Post-market Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 118 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Spinal cord stimulation (SCS) has been shown to be effective for relieving intractable chronic pain. However, a portion of patients who initially succeed with SCS will eventually lose their therapeutic benefit. Reliable methods have not been identified for restoring neuromodulation benefit to this underserved population, so additional research is required. This study will prospectively observe subjects who utilize Abbott neurostimulation devices after failing to sustain pain relief with their previous SCS system. The effectiveness of Abbott systems in restoring neuromodulation benefit will be evaluated over the course of a two-year follow-up.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Burst-capable SCS system | Subjects will be given Burst stimulation using a market-released Abbott SCS system. Burst stimulation may be achieved through surgical or non-surgical means. |
| DEVICE | DRG Stimulator | Subjects will be implanted with a market-released Abbott DRG stimulation system. |
Timeline
- Start date
- 2019-04-16
- Primary completion
- 2021-11-15
- Completion
- 2021-11-15
- First posted
- 2019-04-09
- Last updated
- 2023-08-01
- Results posted
- 2023-01-25
Locations
21 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03908476. Inclusion in this directory is not an endorsement.