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OpenTrials
Completed

NCT Number: NCT03251937

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

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.

Completed

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Key information

Conditions

Chronic Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neurovations, Napa, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spectra WaveWriter SCS System

Device

Multiple modalities of stimulation therapy

Other names: Spectra WaveWriter Spinal Cord Stimulation System

Primary outcomes

  1. Percentage of Subjects With 50% or Greater Reduction in Overall Pain From Baseline

    Time frame: 3 months post activation

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study 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

Acronym: VERITAS

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Aug 16, 2017
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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