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

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03251937
• Collaborator: (none)
• Enrollment: 97
• Locations: 15
• Arm: 1
• Actual Duration (Months): 26
• Patients Per Site: 6.5
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pain; Back Pain	Device: Spectra WaveWriter SCS System	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 97 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 9, 2018
• Actual Primary Completion Date: Jan 9, 2019
• Actual Study Completion Date: Mar 10, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percentage of Subjects With 50% or Greater Reduction in Overall Pain From Baseline [3 months post activation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Neurovations	Napa	California	United States	94558
2	Louis J. Raso, MD, PA	Jupiter	Florida	United States	33477
3	Florida Pain Clinic	Ocala	Florida	United States	34471
4	Forest Health Medical Center	Ypsilanti	Michigan	United States	48198
5	Mercy Medical Research Institute	Springfield	Missouri	United States	65804
6	University of Rochester	Rochester	New York	United States	14618
7	The Center for Clinical Research, LLC	Winston-Salem	North Carolina	United States	27103
8	University Hospitals of Cleveland	Cleveland	Ohio	United States	44106
9	Western Reserve Spine and Pain Institute	Kent	Ohio	United States	44240
10	Toledo Clinic	Toledo	Ohio	United States	43623
11	West Chester Hospital, LLC	West Chester	Ohio	United States	45069
12	Pacific Sports and Spine, LLC	Eugene	Oregon	United States	97401
13	Spine Team Texas	Rockwall	Texas	United States	75032
14	Swedish Neuroscience Institute	Seattle	Washington	United States	98122
15	Advanced Pain Management Appleton	Appleton	Wisconsin	United States	54913

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Study Director: Roshini Jain, Boston Scientific Corporation

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 10, 2019

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT03251937
• Other Study ID Numbers: A4064
• First Posted: Aug 16, 2017
• Last Update Posted: Apr 1, 2021
• Last Verified: Mar 1, 2021

• 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
• Keywords provided by Boston Scientific Corporation: Chronic Pain; Back Pain; Leg Pain; Pain; Stimulation; Spinal Cord Stimulator; Implantable Pulse Generator
• Additional relevant MeSH terms: Back Pain; Chronic Pain

Study Results

Participant Flow

Recruitment Details	Subjects were considered enrolled once informed consent was completed. Only those who met all eligibility criteria went on to receive implant and proceed in the study.

Arm/Group Title	Spinal Cord Stimulation
Arm/Group Description	Spectra WaveWriter SCS System Spectra WaveWriter SCS System: Multiple modalities of stimulation therapy
Period Title: Overall Study
STARTED	40
COMPLETED	37
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Spinal Cord Stimulation
Arm/Group Description	Spectra WaveWriter SCS System Spectra WaveWriter SCS System: Multiple modalities of stimulation therapy
Overall Participants	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.2 (12)
Sex: Female, Male (Count of Participants)
Female	22 55%
Male	18 45%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	40 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects With 50% or Greater Reduction in Overall Pain From Baseline
Time Frame	3 months post activation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Spinal Cord Stimulation
Arm/Group Description	Spectra WaveWriter SCS System Spectra WaveWriter SCS System: Multiple modalities of stimulation therapy
Measure Participants	40
Count of Participants [Participants]	31 77.5%

Adverse Events

Time Frame	Adverse Events were collected through the entire study (up to 1 year post-activation) for all enrolled subjects in the study
Adverse Event Reporting Description	Adverse Events were collected through the entire study (up to 1 year post-activation) for all enrolled subjects in the study
Arm/Group Title	Spinal Cord Stimulation
Arm/Group Description	Spectra WaveWriter SCS System Spectra WaveWriter SCS System: Multiple modalities of stimulation therapy
All Cause Mortality
	Spinal Cord Stimulation
	Affected / at Risk (%)	# Events
Total	1/97 (1%)
Serious Adverse Events
	Spinal Cord Stimulation
	Affected / at Risk (%)	# Events
Total	7/97 (7.2%)
Cardiac disorders
Angina	1/97 (1%)	1
Myocardial Infarction	1/97 (1%)	1
Sinus Node Dysfunction	1/97 (1%)	1
Musculoskeletal and connective tissue disorders
Back Pain	1/97 (1%)	1
Spondylolisthesis	1/97 (1%)	1
Nervous system disorders
Cerebrovascular Accident	1/97 (1%)	1
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism	1/97 (1%)	1
Other (Not Including Serious) Adverse Events
	Spinal Cord Stimulation
	Affected / at Risk (%)	# Events
Total	0/97 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.