Value of Multiple Modalities Using the Spectra WaveWriter Spinal Cord Stimulator System (VERITAS)

Boston Scientific

Status

Completed

Conditions

Back Pain

Chronic Pain

Treatments

Device: Spectra WaveWriter SCS System

Study type

Interventional

Funder types

Industry

Identifiers

NCT03251937

A4064

Details and patient eligibility

About

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 Stimulator (SCS) System.

Enrollment

97 patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

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 Criteria:

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