Trials / Terminated
TerminatedNCT02384096
A Study to Evaluate the Effect of Precision Spectra™ Programming Features and Lead Options on Patient Outcomes
COVERAGE - A Study to Evaluate the Effect of Precision Spectra™ SCS System's Programming Features and Lead Options on Patient Outcomes
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study is a prospective, on-label, multi-center, blinded, randomized controlled trial with a cross-over design to evaluate the effect of Precision Spectra™ SCS System's programming features and lead options.
Detailed description
The study is a sub-study of RELIEF - A Global Registry to Evaluate Long-Term Effectiveness of Neurostimulation Therapy for Pain (NCT01719055). The treatment will consist of permanent implant of a Precision Spectra™ SCS IPG with either a 32 contact CoverEdge™ Surgical Lead or with more than 2 percutaneous leads after a successful trial. Programming features and lead options of the Precision Spectra™ SCS System will be evaluated up to 3 months post-IPG activation. Following completion of the 3 month visit, subjects will continue to be followed for up to 36 months per the study requirements of the RELIEF Registry.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Conventional single source programming | Precision Spectra SCS System using conventional single source programming. |
| DEVICE | Precision Spectra SCS System advanced programming | Precision Spectra SCS System using advanced programming |
Timeline
- Start date
- 2015-02-01
- Primary completion
- 2016-10-01
- Completion
- 2016-10-01
- First posted
- 2015-03-10
- Last updated
- 2020-11-20
- Results posted
- 2018-07-19
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02384096. Inclusion in this directory is not an endorsement.