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

Chronic Pain Clinical Trial

— VERITAS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03251937
• Other study ID #: A4064
• Status: Completed
• Phase: N/A
• Start date: January 9, 2018
• Est. completion date: March 10, 2020

Study information

• Verified date: March 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: March 10, 2020
• Est. primary completion date: January 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain

Intervention

Device:
• Spectra WaveWriter SCS System
Multiple modalities of stimulation therapy

Locations

Country	Name	City	State
United States	Advanced Pain Management Appleton	Appleton	Wisconsin
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Pacific Sports and Spine, LLC	Eugene	Oregon
United States	Louis J. Raso, MD, PA	Jupiter	Florida
United States	Western Reserve Spine and Pain Institute	Kent	Ohio
United States	Neurovations	Napa	California
United States	Florida Pain Clinic	Ocala	Florida
United States	University of Rochester	Rochester	New York
United States	Spine Team Texas	Rockwall	Texas
United States	Swedish Neuroscience Institute	Seattle	Washington
United States	Mercy Medical Research Institute	Springfield	Missouri
United States	Toledo Clinic	Toledo	Ohio
United States	West Chester Hospital, LLC	West Chester	Ohio
United States	The Center for Clinical Research, LLC	Winston-Salem	North Carolina
United States	Forest Health Medical Center	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With 50% or Greater Reduction in Overall Pain From Baseline		3 months post activation