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

  • United States
    • California
      • Napa, California, United States, 94558
        • Neurovations
    • Florida
      • Jupiter, Florida, United States, 33477
        • Louis J. Raso, MD, PA
      • Ocala, Florida, United States, 34471
        • Florida Pain Clinic
    • Michigan
      • Ypsilanti, Michigan, United States, 48198
        • Forest Health Medical Center
    • Missouri
      • Springfield, Missouri, United States, 65804
        • Mercy Medical Research Institute
    • New York
      • Rochester, New York, United States, 14618
        • University of Rochester
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • The Center for Clinical Research, LLC
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland
      • Kent, Ohio, United States, 44240
        • Western Reserve Spine and Pain Institute
      • Toledo, Ohio, United States, 43623
        • Toledo Clinic
      • West Chester, Ohio, United States, 45069
        • West Chester Hospital, LLC
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Pacific Sports and Spine, LLC
    • Texas
      • Rockwall, Texas, United States, 75032
        • Spine Team Texas
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Neuroscience Institute
    • Wisconsin
      • Appleton, Wisconsin, United States, 54913
        • Advanced Pain Management Appleton

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
Device: Spectra WaveWriter SCS System
Multiple modalities of stimulation therapy
Other Names:
  • Spectra WaveWriter Spinal Cord Stimulation System

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

Boston Scientific Corporation

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.

Clinical Trials on Back Pain

Clinical Trials on Spectra WaveWriter SCS System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe