Clinical trial NCT03251937: Value of Multiple Modalities Using the Spectra WaveWriter Spinal Cord Stimulator System
Official title: VERITAS - A Study to Demonstrate the Value of Multiple Modalities Using the Spectra WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Back Pain
Keywords: Chronic Pain
Back Pain
Leg Pain
Pain
Stimulation
Spinal Cord Stimulator
Implantable Pulse Generator
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2017-08-16
Enrollment: 97
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 Stimulator (SCS) System.


Eligibility 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

Primary outcomes:
measure: Percentage of Subjects With 50% or Greater Reduction in Overall Pain From Baseline
timeFrame: 3 months post activation
Secondary outcomes:
Other outcomes:
Locations:
city: Napa
country: United States
facility: Neurovations
state: California
city: Jupiter
country: United States
facility: Louis J. Raso, MD, PA
state: Florida
city: Ocala
country: United States
facility: Florida Pain Clinic
state: Florida
city: Ypsilanti
country: United States
facility: Forest Health Medical Center
state: Michigan
city: Springfield
country: United States
facility: Mercy Medical Research Institute
state: Missouri
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Winston-Salem
country: United States
facility: The Center for Clinical Research, LLC
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
city: Kent
country: United States
facility: Western Reserve Spine and Pain Institute
state: Ohio
city: Toledo
country: United States
facility: Toledo Clinic
state: Ohio
city: West Chester
country: United States
facility: West Chester Hospital, LLC
state: Ohio
city: Eugene
country: United States
facility: Pacific Sports and Spine, LLC
state: Oregon
city: Rockwall
country: United States
facility: Spine Team Texas
state: Texas
city: Seattle
country: United States
facility: Swedish Neuroscience Institute
state: Washington
city: Appleton
country: United States
facility: Advanced Pain Management Appleton
state: Wisconsin
Study officials:
affiliation: Boston Scientific Corporation
name: Roshini Jain
role: STUDY_DIRECTOR
References: