Value of Multiple Modalities Using the Spectra WaveWriter Spinal Cord Stimulator System (VERITAS)
March 8, 2021 updated by: Boston Scientific Corporation
VERITAS - A Study to Demonstrate the Value of Multiple Modalities Using the Spectra WaveWriter™ Spinal Cord Stimulator System in the Treatment of Chronic Pain
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
97
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Napa, California, United States, 94558
- Neurovations
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Florida
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Jupiter, Florida, United States, 33477
- Louis J. Raso, MD, PA
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Ocala, Florida, United States, 34471
- Florida Pain Clinic
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Michigan
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Ypsilanti, Michigan, United States, 48198
- Forest Health Medical Center
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Missouri
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Springfield, Missouri, United States, 65804
- Mercy Medical Research Institute
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New York
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Rochester, New York, United States, 14618
- University of Rochester
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North Carolina
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Winston-Salem, North Carolina, United States, 27103
- The Center for Clinical Research, LLC
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Ohio
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Cleveland, Ohio, United States, 44106
- University Hospitals of Cleveland
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Kent, Ohio, United States, 44240
- Western Reserve Spine and Pain Institute
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Toledo, Ohio, United States, 43623
- Toledo Clinic
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West Chester, Ohio, United States, 45069
- West Chester Hospital, LLC
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Oregon
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Eugene, Oregon, United States, 97401
- Pacific Sports and Spine, LLC
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Texas
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Rockwall, Texas, United States, 75032
- Spine Team Texas
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Washington
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Seattle, Washington, United States, 98122
- Swedish Neuroscience Institute
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Wisconsin
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Appleton, Wisconsin, United States, 54913
- Advanced Pain Management Appleton
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
22 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Spinal Cord Stimulation
Spectra WaveWriter SCS System
|
Multiple modalities of stimulation therapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Percentage of Subjects With 50% or Greater Reduction in Overall Pain From Baseline
Time Frame: 3 months post activation
|
3 months post activation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 9, 2018
Primary Completion (Actual)
January 9, 2019
Study Completion (Actual)
March 10, 2020
Study Registration Dates
First Submitted
August 15, 2017
First Submitted That Met QC Criteria
August 15, 2017
First Posted (Actual)
August 16, 2017
Study Record Updates
Last Update Posted (Actual)
April 1, 2021
Last Update Submitted That Met QC Criteria
March 8, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A4064
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.