NCT03251937

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable chronic-pain

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable chronic-pain

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 16, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

January 9, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2020

Completed
6 days until next milestone

Results Posted

Study results publicly available

March 16, 2020

Completed
Last Updated

April 1, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

August 15, 2017

Results QC Date

January 21, 2020

Last Update Submit

March 8, 2021

Conditions

Chronic PainBack Pain

Keywords

Chronic PainBack PainLeg PainPainStimulationSpinal Cord StimulatorImplantable Pulse Generator

Outcome Measures

Primary Outcomes (1)

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

    3 months post activation

Study Arms (1)

Spinal Cord Stimulation

EXPERIMENTAL

Spectra WaveWriter SCS System

Device: Spectra WaveWriter SCS System

Interventions

Spectra WaveWriter SCS SystemDEVICE

Multiple modalities of stimulation therapy

Also known as: Spectra WaveWriter Spinal Cord Stimulation System
Spinal Cord Stimulation

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic pain of the trunk and/or limbs
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Neurovations

Napa, California, 94558, United States

Location

Louis J. Raso, MD, PA

Jupiter, Florida, 33477, United States

Location

Florida Pain Clinic

Ocala, Florida, 34471, United States

Location

Forest Health Medical Center

Ypsilanti, Michigan, 48198, United States

Location

Mercy Medical Research Institute

Springfield, Missouri, 65804, United States

Location

University of Rochester

Rochester, New York, 14618, United States

Location

The Center for Clinical Research, LLC

Winston-Salem, North Carolina, 27103, United States

Location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Western Reserve Spine and Pain Institute

Kent, Ohio, 44240, United States

Location

Toledo Clinic

Toledo, Ohio, 43623, United States

Location

West Chester Hospital, LLC

West Chester, Ohio, 45069, United States

Location

Pacific Sports and Spine, LLC

Eugene, Oregon, 97401, United States

Location

Spine Team Texas

Rockwall, Texas, 75032, United States

Location

Swedish Neuroscience Institute

Seattle, Washington, 98122, United States

Location

Advanced Pain Management Appleton

Appleton, Wisconsin, 54913, United States

Location

MeSH Terms

Conditions

Chronic PainBack PainPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Director of Clinical Sciences
Organization
Boston Scientific
roshini.jain@bsci.com
661 949 4350

Study Officials

  • Roshini Jain

    Boston Scientific Corporation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2017

First Posted

August 16, 2017

Study Start

January 9, 2018

Primary Completion

January 9, 2019

Study Completion

March 10, 2020

Last Updated

April 1, 2021

Results First Posted

March 16, 2020

Record last verified: 2021-03

Locations

US(15)