Value of Multiple Modalities Using the Spectra WaveWriter Spinal Cord Stimulator System (VERITAS)
Primary Purpose
Chronic Pain, Back Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spectra WaveWriter SCS System
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Chronic Pain, Back Pain, Leg Pain, Pain, Stimulation, Spinal Cord Stimulator, Implantable Pulse Generator
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
Sites / Locations
- Neurovations
- Louis J. Raso, MD, PA
- Florida Pain Clinic
- Forest Health Medical Center
- Mercy Medical Research Institute
- University of Rochester
- The Center for Clinical Research, LLC
- University Hospitals of Cleveland
- Western Reserve Spine and Pain Institute
- Toledo Clinic
- West Chester Hospital, LLC
- Pacific Sports and Spine, LLC
- Spine Team Texas
- Swedish Neuroscience Institute
- Advanced Pain Management Appleton
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Spinal Cord Stimulation
Arm Description
Spectra WaveWriter SCS System
Outcomes
Primary Outcome Measures
Percentage of Subjects With 50% or Greater Reduction in Overall Pain From Baseline
Secondary Outcome Measures
Full Information
NCT ID
NCT03251937
First Posted
August 15, 2017
Last Updated
March 8, 2021
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT03251937
Brief Title
Value of Multiple Modalities Using the Spectra WaveWriter Spinal Cord Stimulator System
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 9, 2018 (Actual)
Primary Completion Date
January 9, 2019 (Actual)
Study Completion Date
March 10, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Back Pain
Keywords
Chronic Pain, Back Pain, Leg Pain, Pain, Stimulation, Spinal Cord Stimulator, Implantable Pulse Generator
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spinal Cord Stimulation
Arm Type
Experimental
Arm Description
Spectra WaveWriter SCS System
Intervention Type
Device
Intervention Name(s)
Spectra WaveWriter SCS System
Other Intervention Name(s)
Spectra WaveWriter Spinal Cord Stimulation System
Intervention Description
Multiple modalities of stimulation therapy
Primary Outcome Measure Information:
Title
Percentage of Subjects With 50% or Greater Reduction in Overall Pain From Baseline
Time Frame
3 months post activation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roshini Jain
Organizational Affiliation
Boston Scientific Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Neurovations
City
Napa
State/Province
California
ZIP/Postal Code
94558
Country
United States
Facility Name
Louis J. Raso, MD, PA
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33477
Country
United States
Facility Name
Florida Pain Clinic
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Forest Health Medical Center
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48198
Country
United States
Facility Name
Mercy Medical Research Institute
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
The Center for Clinical Research, LLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Western Reserve Spine and Pain Institute
City
Kent
State/Province
Ohio
ZIP/Postal Code
44240
Country
United States
Facility Name
Toledo Clinic
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
West Chester Hospital, LLC
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Facility Name
Pacific Sports and Spine, LLC
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Spine Team Texas
City
Rockwall
State/Province
Texas
ZIP/Postal Code
75032
Country
United States
Facility Name
Swedish Neuroscience Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Advanced Pain Management Appleton
City
Appleton
State/Province
Wisconsin
ZIP/Postal Code
54913
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Value of Multiple Modalities Using the Spectra WaveWriter Spinal Cord Stimulator System
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