Chronic PainVERITASNCT03251937
Value of Multiple Modalities Using the Spectra WaveWriter Spinal Cord Stimulator System
A study testing Spectra WaveWriter SCS System in people with Chronic Pain and Back Pain, run by Boston Scientific Corporation at 15 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Chronic Pain, Back Pain
- What is being tested?
- Spectra WaveWriter SCS System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 15 sitesUnited States
- Study dates
- 9 Jan 2018to 10 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Advanced Pain Management Appleton
Appleton, Wisconsin, 54913
University Hospitals of Cleveland
Cleveland, Ohio, 44106
Pacific Sports and Spine, LLC
Eugene, Oregon, 97401
Louis J. Raso, MD, PA
Jupiter, Florida, 33477
Western Reserve Spine and Pain Institute
Kent, Ohio, 44240
Neurovations
Napa, California, 94558
Florida Pain Clinic
Ocala, Florida, 34471
University of Rochester
Rochester, New York, 14618
Spine Team Texas
Rockwall, Texas, 75032
Swedish Neuroscience Institute
Seattle, Washington, 98122
Mercy Medical Research Institute
Springfield, Missouri, 65804
Toledo Clinic
Toledo, Ohio, 43623
West Chester Hospital, LLC
West Chester, Ohio, 45069
The Center for Clinical Research, LLC
Winston-Salem, North Carolina, 27103
Forest Health Medical Center
Ypsilanti, Michigan, 48198
About this study
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
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.
- Conditions
- Chronic Pain, Back Pain
- Being tested
- Spectra WaveWriter SCS System
- Keywords
- Chronic Pain, Back Pain, Leg Pain, Pain, Stimulation, Spinal Cord Stimulator, Implantable Pulse Generator
- Medical subject headings
- Chronic Pain, Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectra WaveWriter SCS SystemDevice
Also called Spectra WaveWriter Spinal Cord Stimulation System
Multiple modalities of stimulation therapy
| Study group | Role | What they receive |
|---|---|---|
| Spinal Cord Stimulation | Experimental | Spectra WaveWriter SCS System Receives: Device: Spectra WaveWriter SCS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With 50% or Greater Reduction in Overall Pain From Baseline
Measured: 3 months post activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study start9 Jan 2018
- Primary completion9 Jan 2019
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roshini Jain, Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251937
- Sponsor's protocol ID
- A4064
- Acronym
- VERITAS
- Status last verified
- Mar 2021
- First submitted
- 15 Aug 2017
- Last updated
- 1 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03251937
- Acronym / sponsor ID
- VERITAS / A4064
- Conditions
- Chronic Pain, Back Pain
- Keywords
- Chronic Pain, Back Pain, Leg Pain, Pain, Stimulation, Spinal Cord Stimulator, Implantable Pulse Generator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 9 Jan 2019 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 16 Aug 2017 (actual)
- Results
- Posted 16 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal Cord Stimulation | Experimental | Device: Spectra WaveWriter SCS SystemSpectra WaveWriter SCS System |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spectra WaveWriter SCS SystemAlso: Spectra WaveWriter Spinal Cord Stimulation SystemMultiple modalities of stimulation therapy | Device | Spinal Cord Stimulation |
Primary outcome
Percentage of Subjects With 50% or Greater Reduction in Overall Pain From Baseline
Time frame: 3 months post activation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roshini Jain study director
Boston Scientific Corporation
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spectra WaveWriter SCS System in people with Chronic Pain and Back Pain, run by Boston Scientific Corporation at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects With 50% or Greater Reduction in Overall Pain From Baseline (time frame: 3 months post activation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.