Status:
COMPLETED
Value of Multiple Modalities Using the Spectra WaveWriter Spinal Cord Stimulator System
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Chronic Pain
Back Pain
Eligibility:
All Genders
22+ years
Phase:
NA
Brief Summary
To demonstrate the value of multiple modalities and sustained clinically significant pain relief in patients with chronic pain when using the Boston Scientific Spectra WaveWriter Spinal Cord Stimulato...
Eligibility Criteria
Inclusion
- Key
- Chronic pain of the trunk and/or limbs
- 22 years of age or older at time of enrollment
- Willing and able to comply with all protocol-required procedures and assessments/evaluations provided in English
- Willing and capable of giving informed consent
- Key
Exclusion
- Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment, might confound reporting of study outcomes
- Significant cognitive impairment that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study
- Current systemic infection, or local infection in close proximity to the anticipated surgical field
- Breast-feeding, pregnant or planning to get pregnant during the course of the study or not using adequate contraception
- Previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
- Participating, or intends to participate, in another clinical trial that may influence the data that will be collected for this study
Key Trial Info
Start Date :
January 9 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2020
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT03251937
Start Date
January 9 2018
End Date
March 10 2020
Last Update
April 1 2021
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Neurovations
Napa, California, United States, 94558
2
Louis J. Raso, MD, PA
Jupiter, Florida, United States, 33477
3
Florida Pain Clinic
Ocala, Florida, United States, 34471
4
Forest Health Medical Center
Ypsilanti, Michigan, United States, 48198