Trials / Completed
CompletedNCT03689920
Combining Mechanisms for Better Outcomes (COMBO)
Study to Demonstrate the Value of Multiple Modalities and Combining Mechanisms Using the Spectra WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 174 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities as compared to conventional SCS in patients with chronic pain when using the Boston Scientific Spectra WaveWriter SCS System.
Detailed description
To evaluate the effectiveness of Spinal Cord Stimulation (SCS) with multiple modalities as compared to conventional SCS in patients with chronic pain when using the Boston Scientific Spectra WaveWriter SCS System.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Boston Scientific Spectra WaveWriter™ Spinal Cord Stimulation (SCS) System | The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain. |
Timeline
- Start date
- 2018-10-03
- Primary completion
- 2019-11-05
- Completion
- 2021-12-15
- First posted
- 2018-10-01
- Last updated
- 2022-01-11
- Results posted
- 2020-11-27
Locations
15 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03689920. Inclusion in this directory is not an endorsement.